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Spots Global Cancer Trial Database for Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer

Official Title: A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)

Study ID: NCT00003364

Conditions

Lung Cancer

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with radiation therapy may kill more tumor cells. The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known . PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer.

Detailed Description: OBJECTIVES: I. Determine whether long term survival is affected by the timing of thoracic radiotherapy in patients with limited stage small cell lung cancer who are receiving combination chemotherapy. II. Determine whether the development of local recurrence and distant metastases are affected by the timing of thoracic radiotherapy in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. All patients receive cyclophosphamide, doxorubicin, and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes. This treatment alternates every 3 weeks for six courses. Patients are randomized to have thoracic radiotherapy either with course 2 (arm I) or with course 6 (arm II) of chemotherapy. Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy. If there is no disease progression after chemotherapy and locoregional irradiation, and a repeat brain scan is negative, patients receive prophylactic brain irradiation. Patients are followed monthly for the first year and then every 2 months thereafter. PROJECTED ACCRUAL: This study will accrue 398 patients.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Heatherwood Hospital, Ascot, England, United Kingdom

Royal Sussex County Hospital, Brighton, England, United Kingdom

Addenbrooke's NHS Trust, Cambridge, England, United Kingdom

Broomfield Hospital, Chelmsford, Essex, England, United Kingdom

Essex County Hospital, Colchester, England, United Kingdom

Royal Free Hospital, Hampstead, London, England, United Kingdom

Cookridge Hospital, Leeds, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

Guy's and St. Thomas' Hospitals Trust, London, England, United Kingdom

Charing Cross Hospital, London, England, United Kingdom

Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom

Mount Vernon Hospital, Northwood, England, United Kingdom

Peterborough Hospitals Trust, Peterborough, England, United Kingdom

Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom

Contact Details

Name: Stephen G. Spiro

Affiliation: University College London Hospitals

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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