A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 8
- 主要终点
- Toxicity of both treatments
研究概览
简要总结
The study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery.
Hypothesis(es) to be tested:
- Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting
- Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting
- Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy
详细描述
A third of patients with non-small cell lung cancer (NSCLC) present with Stage IIIA or IIIB disease, which is not amenable to curative resection. Single modality local therapy, either surgery or radiation, only cures a fraction of such patients.
Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB non-small cell lung cancer, based upon the extent of the loco-regional disease or the medical state of the patient. Patients of good performance status receiving protracted high-dose palliative radiotherapy do obtain a survival benefit from this therapy. Studies have shown a survival advantage by adding chemotherapy to radical radiation therapy: but studies in the high-dose palliative radiotherapy setting are lacking. Two regimens of concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally, with established MTDs. These 2 regimens do warrant a comparative assessment in a phase II trial, prior to a phase III trial against high dose palliative radiation alone (36Gy/12#/5).
This is a randomised phase II trial comprising of 2 arms for randomization as follows:
Arm A:External beam radiation, 40 Gy/20#/5 per week, Plus concurrent Vinorelbine, IV, 25mg/m2, days 1, 8, 22 and + Cisplatin 20mg/m2, IV, weekly
Arm B:External beam radiation, 30 Gy/15#/5 per week, Plus concurrentGemcitabine, 200mg (flat dose) IV days 1, 8, 15
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
- •Histologically or cytologically proven non-small cell lung cancer.
- •Planned high dose palliative radiation therapy for locoregional control. Examples include patients with:
- •Stage I - IIIB disease with
- •disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or
- •concurrent medical illness
- •Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a FDG-PET only solitary metastasis.
- •All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.
- •No prior radiotherapy or chemotherapy for non-small cell lung cancer.
- •ECOG performance status 0,
- •Adequate hepatic, bone marrow and renal function.
- •If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.
- •Written informed consent.
排除标准
- •Patient unable to receive all therapy as an outpatient.
- •Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- •History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
- •Receiving treatment with another investigational agent.
研究组 & 干预措施
A
Vinorelbine + cisplatin + high-dose palliative radiotherapy
干预措施: High Dose Radiotherapy (Radiation)
A
Vinorelbine + cisplatin + high-dose palliative radiotherapy
干预措施: Vinorelbine (Drug)
A
Vinorelbine + cisplatin + high-dose palliative radiotherapy
干预措施: Cisplatin (Drug)
B
Gemcitabine + high-dose palliative radiotherapy
干预措施: Gemcitabine (Drug)
B
Gemcitabine + high-dose palliative radiotherapy
干预措施: High Dose Radiotherapy (Radiation)
结局指标
主要结局
Toxicity of both treatments
时间窗: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Objective response rate (RECIST criteria)
时间窗: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Symptomatic response rate
时间窗: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
The feasibility (i.e. % of patients who cannot complete the planned RT dose or who require a break for toxicity) and problems encountered with protocol compliance in the setting of a multi-institutional TROG study.
时间窗: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
次要结局
- Progression-free survival(Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.)
- QOL as assessed by FACT-L version 4.(Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.)