NCT01687413终止3 期
Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of Participants With Disease-free Survival (DFS)
研究概览
简要总结
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
- •Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
- •Patient's disease must be pathological N-stage positive.
- •Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
- •Patients with synchronous primaries are included.
- •Patients with unknown primaries are included if the diagnosis and resection of a primary site in the oropharynx is made from an endoscopic or robotic surgical procedure(s).
- •Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.
- •Patient must be ≥ 21 years of age.
- •ECOG performance status ≤ 2 (Karnofsky ≥60%).
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes ≥3,000/mcL
- •absolute neutrophil count ≥1,500/mcL
- •platelets ≥100,000/mcL
- •total bilirubin <1.5 X upper normal institutional limit
- •AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
排除标准
- •Patient must not have pathologically N stage negative disease.
- •Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
- •Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
- •Patient must not have distant metastatic disease at presentation.
- •Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
- •Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor.
- •Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
- •Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable).
- •Patient must not be receiving any other investigational agents.
- •Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception.
- •Both men and women and members of all races and ethnic groups are eligible for this trial.
研究组 & 干预措施
Radiotherapy
Experimental
- Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
- Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
干预措施: Intensity-modulated radiation therapy (IMRT) (Radiation)
Radiotherapy, cisplatin
Active Comparator
- Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
- Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
- Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
干预措施: Intensity-modulated radiation therapy (IMRT) (Radiation)
Radiotherapy, cisplatin
Active Comparator
- Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
- Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
- Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of Participants With Disease-free Survival (DFS)
时间窗: 1 year
Locoregional Control
时间窗: Up to 2 years
Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
次要结局
- Disease Specific Survival(1 year)
- Change in Cognitive Function as Measured by Cognitive Failures Questionnaire(Baseline, 1 month, 12 months, and 24 months)
- Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity(Baseline, 1 month, 6 months, and 12 months)
- Rate of Distant Metastasis(Up to 2 years)
- Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory(Baseline, 1 month, 6 months, 12 months, and 24 months)
- Change in Quality of Life as Measured by EORTC QLQ-C30(Baseline, 1 month, 6 months, 12 months, and 24 months)
- Number of Complications/Acute Toxicity by Organ Class(Approximately 18 weeks)
- Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)(Baseline, 12 months, and 24 months)
- Change in Quality of Life as Measured by Speech Handicap Index(Baseline and 12 months)
- Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire(Baseline, 1 month, 6 months, 12 months, and 24 months)
- Change in Hearing as Measured by Hearing Handicap Inventory - Adult(Baseline, 1 month, and 12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal CancerStage III Oropharyngeal Squamous Cell CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaTongue CarcinomaNCT02254278NRG Oncology316
招募中
2 期
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck CancerHead and Neck CarcinomaHead and Neck NeoplasmsHead and Neck Squamous Cell CarcinomaHead and Neck CancerNCT05544136Memorial Sloan Kettering Cancer Center12
已完成
3 期
BILCAP: A research trial evaluating chemotherapy in patients following surgery for biliary tract cancerCancerISRCTN72785446The University of Southampton447
招募中
1 期
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHNSCCNCT06016920Nykode Therapeutics ASA110
终止
1 期
Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid TumorsSolid TumorsNCT01548924Centro Nacional de Investigaciones Oncologicas CARLOS III13