Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival of patients with completely resected non-small cell lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy.
Secondary
- Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens in these patients.
- Compare the local control in patients treated with these regimens.
- Determine patterns of recurrence in patients treated with these regimens.
- Determine the overall survival of patients treated with these regimens.
- Assess second cancers in patients treated with these regimens.
- Assess prognostic factors and predictive factors of treatment effect on disease-free survival and overall survival of patients treated with these regimens.
- Determine the cost per recurrence-free year of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological evidence of non-small cell lung cancer (NSCLC)
- •Complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins) or extra-capsular mediastinal nodal extension breaching the surface of the pathological specimen should not to be included
- •Mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended)
- •Pathologically or cytologically documented N2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint AJCC and UICC classification, clinical N2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed N2 disease at the time of surgery
- •Prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
- •Patient aged ≥ 18 years
- •Good Performance status (WHO ≤ 2)
- •Fit enough to receive curative radiotherapy
- •Adequate pulmonary function with post-operative FEV1 after surgery > 1 l or over 35% theoretical value
- •Signed informed consent form
排除标准
- •Documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy)
- •Major pleural or pericardial effusion
- •Synchronous contra-lateral lung cancer
- •Clinical progression during post-operative chemotherapy
- •Previous chest radiotherapy
- •Intention of concomitant chemotherapy during radiotherapy
- •Weight loss in the previous 6 months before surgery ≥ 10 %
- •Evidence of severe or uncontrolled systemic disease as judged by the investigator
- •Recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
- •Current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :
- •basal cell carcinoma of the skin
- •in situ carcinoma of the cervix A patient diagnosed for another neoplasm 5 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected.
- •Pregnancy or breast feeding or inadequate contraceptive measures during treatment
- •Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
- •Patient deprived of freedom or under guardianship
研究组 & 干预措施
Radiotherapy
Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
干预措施: adjuvant therapy (Procedure)
Radiotherapy
Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Radiotherapy
Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
干预措施: clinical observation (Other)
No radiotherapy
Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.
干预措施: clinical observation (Other)
No radiotherapy
Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward
次要结局
- Prognostic and predictive factors of treatment effect on DFS and OS(assessed up at the end of the study)
- Acute and late toxicity (with identification of predictive factors of toxicity)(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Patterns of failure(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Overall survival (OS)(assessed up In case of death whatever the cause)
- Cost per recurrence-free year of life(Assessed up at the end of the study)
- Local control(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Second cancers(Assessed up in case of event)