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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003364
• Other study ID #: CDR0000066349
• Secondary ID: LLCG-TR8SCLCEU-9
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: January 1993
• Est. completion date: August 2006

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 74 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Limited disease defined as within the hemithorax, mediastinum, or ipsilateral supraclavicular nodes No evidence of extensive disease (i.e., contralateral lung or contralateral supraclavicular nodes) No metastatic disease Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: ECOG 0-3 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine normal OR Creatinine clearance greater than 50 mL/min OR Pentetic acid/ethylenediaminetetraacetic acid clearance greater than 70 mL/min Cardiovascular: No myocardial infarction in the 3 months prior to diagnosis No pericardial effusion Pulmonary: No pleural effusion seen on chest x-ray Pleural effusion identified on CT allowed, if not visible on chest x-ray Other: No medical condition that excludes the use of chemotherapy or thoracic irradiation Must be able to tolerate the prescribed study radiotherapy No other malignant tumor for at least 3 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent prednisone or other corticosteroids for hypercalcemia allowed Radiotherapy: No prior radiotherapy Surgery: Not specified

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	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	Charing Cross Hospital	London	England
United Kingdom	Guy's and St. Thomas' Hospitals Trust	London	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Saint Bartholomew's Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
London Lung Cancer Group

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Spiro SG, James LE, Rudd RM, Trask CW, Tobias JS, Snee M, Gilligan D, Murray PA, Ruiz de Elvira MC, O'Donnell KM, Gower NH, Harper PG, Hackshaw AK; London Lung Cancer Group. Early compared with late radiotherapy in combined modality treatment for limited — View Citation