A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Radiation Therapy Oncology Group213 个研究点分布在 1 个国家目标入组 544 人2007年11月

适应症Lung Cancer Radiation Toxicity

干预措施Carboplatin 74 Gy RT Paclitaxel 60 Gy RT Cetuximab

概览

阶段: 3 期
干预措施: Carboplatin
疾病 / 适应症: Lung Cancer
发起方: Radiation Therapy Oncology Group
入组人数: 544
试验地点: 213
主要终点: Overall Survival
状态: 已完成
最后更新: 3年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin 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 high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

详细描述

OBJECTIVES: Primary * To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel. * To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy Secondary * To compare progression-free survival and local-regional tumor control in patients treated with these regimens. * To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients. * To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens. * To compare the quality of life of patients treated with these regimens. * To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters. * To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens. * To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens. * To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens. * To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival. OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy), Zubrod performance status (0 vs 1), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4 treatment arms. (Arms II and IV closed to accrual effective 6/17/11) Patients may undergo tumor tissue, blood, and urine collection periodically during study for tissue banking or biomarker correlative studies. Patients may undergo quality-of-life assessment at baseline and periodically during study. After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.

注册库

clinicaltrials.gov

开始日期

2007年11月

结束日期

2022年5月20日

最后更新

3年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Radiation Therapy Oncology Group

责任方

Sponsor

入排标准

入选标准

未提供

排除标准

•N3 supraclavicular disease;
•Greater than minimal, exudative, or cytologically positive pleural effusions;
•Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan);
•≥ 10% weight loss within the past month;
•Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as 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;
•Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway;
•Prior severe infusion reaction to a monoclonal antibody;
•Severe, active co-morbidity, defined as follows:

研究组 & 干预措施

时间窗: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

次要结局

Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Local-regional Failure (Reported as Two-year Estimates)(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Death During or Within 30 Days of Discontinuation of Protocol Treatment(From start of protocol treatment to 24 months.)
Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).(At baseline and 3 months.)
Patient-reported Swallowing Score (Area Under the Curve)(From randomization to 6 weeks after start of radiation therapy (6-10 weeks from randomization))
EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)(From randomization to one year)
Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Percentage of Patients With Grade 3+ Adverse Events by Epithelial Growth Factor Receptor (EGFR) Group(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Prognostic and Predictive Effects of Gross Tumor Volume (GTV) on Overall Survival(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
Progression-free Survival(From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)