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临床试验/NCT01302834
NCT01302834已完成3 期

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Radiation Therapy Oncology Group369 个研究点 分布在 1 个国家目标入组 987 人开始时间: 2011年6月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
987
试验地点
369
主要终点
Overall Survival
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

详细描述

OBJECTIVES:

Primary

  • To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.

Secondary

  • To monitor and compare progression-free survival for "safety".
  • To compare patterns of failure (locoregional vs distant).
  • To compare acute toxicity profiles (and overall toxicity burden).
  • To compare overall quality of life (QOL) short-term (< 6 months) and long-term (1 year).
  • To compare QOL Swallowing Domains short-term and long-term.
  • To compare clinician-reported versus patient-reported CTCAE toxicity events.
  • To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
  • To explore differences in work status and time to return to work.
  • To compare patient-reported changes in hearing.
  • To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
  • To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.
  • To pilot CASI collection of patient reported outcomes in a cooperative group setting.
  • To determine whether specific molecular profiles are associated with overall or progression-free survival.
  • To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 120 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls).
  • •Patients must be positive for p16, determined by central review prior to randomization.
  • •Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck are insufficient due to limited tissue for retrospective central review. Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required.
  • •Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III), including no distant metastases, based upon the following minimum diagnostic workup:
  • •General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration;
  • •Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration;
  • •One of the following combinations of imaging is required within 8 weeks prior to registration:
  • •A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
  • •or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
  • •or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast);
  • •or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
  • •Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools.
  • •Zubrod Performance Status 0-1 within 2 weeks prior to registration
  • •Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows:
  • •Absolute neutrophil count (ANC) > 1,500 cells/mm3;
  • •Platelets > 100,000 cells/mm3;
  • •Hemoglobin (Hgb) > 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.
  • •Adequate hepatic function, defined as follows:
  • •Bilirubin < 2 mg/dl within 2 weeks prior to registration;
  • •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal within 2 weeks prior to registration;
  • •Adequate renal function, defined as follows:
  • •Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration or creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:
  • •CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCr male)
  • •Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool.
  • •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
  • •Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until at least 60 days following the last study treatment.
  • •Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. Patient HIV status must be known prior to registration. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions.
  • •Patient must provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review and consent to participate in the computer-assisted self interview (CASI) survey questions regarding smoking history.

排除标准

  • •Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive, are excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive) are excluded from participation.
  • •Stage T1-2, N0-1;
  • •Distant metastasis or adenopathy below the clavicles;
  • •Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
  • •Simultaneous primaries or bilateral tumors;
  • •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
  • •Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
  • •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • •Severe, active co-morbidity, defined as follows:
  • •9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  • •9.2 Transmural myocardial infarction within the last 6 months;
  • •9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • •9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
  • •9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • •9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Section 3.1.13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • •Prior allergic reaction to cisplatin or cetuximab;
  • •Prior cetuximab or other anti-EGFR therapy.

研究组 & 干预措施

IMRT + Cetuximab

Active Comparator

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

干预措施: IMRT (Radiation)

IMRT + Cisplatin

Active Comparator

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

干预措施: IMRT (Radiation)

IMRT + Cetuximab

Active Comparator

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

干预措施: cetuximab (Biological)

IMRT + Cisplatin

Active Comparator

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

干预措施: cisplatin (Drug)

结局指标

主要结局

Overall Survival

时间窗: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

次要结局

  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment(Baseline and end of treatment (6-7 weeks))
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment(Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment(Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment(Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment(Baseline and end of treatment (6-7 weeks))
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.(Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.(Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.(Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.)
  • Percentage of Patients With Normal/Good Dental Health: Pretreatment(Before treatment)
  • Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment(1 year after end of treatment (approximately 13.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment(2 years after end of treatment (approximately 25.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment(5 years after end of treatment (approximately 61.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment(10 years after end of treatment (approximately 121.5 months))
  • Number of Participants by HHIA-S Category at Baseline(Baseline)
  • Number of Participants by HHIA-S Category at End of Treatment(End of treatment (6-7 weeks))
  • Number of Participants by HHIA-S Category at 3 Months After End of Treatment(3 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Number of Participants by HHIA-S Category at 6 Months After End of Treatment(6 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Number of Participants by HHIA-S Category at 12 Months After End of Treatment(12 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Progression-free Survival(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Local-regional Failure(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Distant Metastasis(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Secondary Primary Cancer(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Distribution of First Progression Events(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Percentage of Participants Experiencing Early Death(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment(From start of treatment to end of treatment, approximately 6 weeks)
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment(From start of treatment to approximately 2.5 months (1 month after the end of treatment))
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment(From start of treatment to approximately 4.5 months (3 months after the end of treatment))
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment(From start of treatment to approximately 7.5 months (6 months after the end of treatment))
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment(From start of treatment to approximately 13.5 months (one year after the end of treatment))
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment(From 180 days after end of treatment to two years after end of treatment.)
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment(From start of treatment to approximately 61.5 months (five years after the end of treatment))
  • Percentage of Participants With a Feeding Tube at 1 Year(From randomization to 1 year.)
  • Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Progression-free Survival by KRAS Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Overall Survival by Treatment Arm Within KRAS Variant Status Group(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Progression-free Survival Within KRAS Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Number of Participants With Post-baseline Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) Scores >= 3(End of treatment (approximately 6 weeks after baseline); and 3, 6, and 12 months after end of treatment (approximately 4.5, 7.5, and 13.5 months after baseline).)
  • EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Index Score Change From Baseline(Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.)
  • EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Visual Analogue Scale (VAS) Change From Baseline(Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.)
  • Number of Participants by Work Status Category at Baseline(Baseline)
  • Number of Participants by Work Status Category at End of Treatment(End of treatment (6-7 weeks))
  • Number of Participants by Work Status Category at 3 Months After End of Treatment(Three months after end of treatment (6-7 weeks).)
  • Number of Participants by Work Status Category at 6 Months After End of Treatment(Six months after end of treatment (6-7 weeks).)
  • Number of Participants by Work Status Category at 12 Months After End of Treatment(Twelve months after end of treatment (6-7 weeks).)
  • Progression-free Survival(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Local-regional Failure(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Distant Metastasis(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Time to Secondary Primary Cancer(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Distribution of First Progression Events(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Percentage of Participants Experiencing Early Death(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.)
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment(From start of treatment to end of treatment, approximately 6 weeks)
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment(From start of treatment to approximately 2.5 months (1 month after the end of treatment))
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment(From start of treatment to approximately 4.5 months (3 months after the end of treatment))
  • Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment(From start of treatment to approximately 7.5 months (6 months after the end of treatment))
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment(From start of treatment to approximately 13.5 months (one year after the end of treatment))
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment(From 180 days after end of treatment to two years after end of treatment.)
  • Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment(From start of treatment to approximately 61.5 months (five years after the end of treatment))
  • Percentage of Participants With a Feeding Tube at 1 Year(From randomization to 1 year.)
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment(Baseline and end of treatment (6-7 weeks))
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment(Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment(Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment(Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment(Baseline and end of treatment (6-7 weeks))
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.(Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.(Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.)
  • EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.(Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.)
  • Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.(From randomization to 1 year after end of treatment.)
  • EuroQol Five Dimension Scale (EQ-5D) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.(From randomization to 1 year after end of treatment.)
  • Work Status Questionnaire at Baseline, End of Treatment, 3, 6, and 12 Months.(From randomization to 1 year after end of treatment.)
  • Percentage of Patients With Normal/Good Dental Health: Pretreatment(Before treatment)
  • Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment(1 year after end of treatment (approximately 13.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment(2 years after end of treatment (approximately 25.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment(5 years after end of treatment (approximately 61.5 months))
  • Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment(10 years after end of treatment (approximately 121.5 months))
  • Number of Participants by HHIA-S Category at Baseline(Baseline)
  • Number of Participants by HHIA-S Category at End of Treatment(End of treatment (6-7 weeks))
  • Number of Participants by HHIA-S Category at 3 Months After End of Treatment(3 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Number of Participants by HHIA-S Category at 6 Months After End of Treatment(6 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Number of Participants by HHIA-S Category at 12 Months After End of Treatment(12 months after end of treatment. Treatment lasts 6-7 weeks.)
  • Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Progression-free Survival by KRAS Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Overall Survival by Treatment Arm Within KRAS Variant Status Group(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)
  • Progression-free Survival Within KRAS Variant Status(From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (369)

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