A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Treatment related mortality (any cause)
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control).
- Compare the hematological, pulmonary, esophageal, and neurological toxicities.
- Compare the response.
- Compare the quality of life.
- Compare the cost-effectiveness.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Treatment related mortality (any cause)
Time Frame: from randomization till death
Secondary Outcomes
- Cost effectiveness(at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter)
- Hematological, pulmonary, esophageal, and neurological toxicities(From randomisation to the first 6 months)
- Quality of life(at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter)
- Overall survival and progression-free survival.(Overall Survival is the time between date of randomisation and date of death of any cause. Progression-free survival will be calculated from the date of randomisation to the date of first clinical evidence of progressive disease, or death.)
- Local progression-free survival (local control)(From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death)
- Response(proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported.)