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Sponsored by: |
Christie Hospital NHS Foundation Trust |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00433563 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, 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 which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: etoposide Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT] |
Estimated Enrollment: | 532 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and lactic dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions).
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 532 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
No more than 1 of the following adverse factors:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Cancer Research Centre at Weston Park Hospital | Recruiting |
Sheffield, England, United Kingdom, S1O 2SJ | |
Contact: Penella J. Woll, MD, PhD 44-114-226-5206 | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: Corinne Faivre-Finn, MD 44-1-61-446-3000 corinne.finn@christie-tr.nwest.nhs.uk | |
Cookridge Hospital | Recruiting |
Leeds, England, United Kingdom, LS16 6QB | |
Contact: Michael Snee, MD 44-113-392-4347 michael.snee@leedsth.nhs | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
Northwood, England, United Kingdom, HA6 2RN | |
Contact: Ethan Lyn, MD 44-1923-844-551 ethanlyn@mac.com | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Contact: Rhona McMenemin 44-191-219-4200 | |
University College Hospital | Recruiting |
London, England, United Kingdom, NW1 2PG | |
Contact: Siow M. Lee, MD, PhD, FRCP 44-20-7380-9091 sm.lee@uclh.org | |
United Kingdom, Scotland | |
Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Contact: Nazia Mohammed 44-141-211-6205 | |
Edinburgh Cancer Centre at Western General Hospital | Recruiting |
Edinburgh, Scotland, United Kingdom, EH4 2XU | |
Contact: Allan Price, MD 0131-537-2204/5 A.Price@ed.ac.uk |
Study Chair: | Corinne Faivre-Finn, MD | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000531709, CHNT-CONVERT, CHNT-CTAAC-CONVERT-C17052/A815, EU-20669 |
Study First Received: | February 8, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00433563 |
Health Authority: | Unspecified |
limited stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Neoplasms, Nerve Tissue Antineoplastic Agents, Phytogenic Pharmacologic Actions |