Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

Phase 3

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00005062
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

Detailed Description

OBJECTIVES:

* Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission.

* Evaluate the quality of life and late sequelae in this patient population treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose.

* Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days).

* Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center.

* 18 fractions/24 days (conventional radiotherapy) OR

* 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy.

Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter.

Patients are followed at least every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2000-04-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of brain metastases 2 years after randomization

Secondary Outcome Measures

Name	Time	Method
Overall survival and disease-free survival 2 years after randomization
Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter

Trial Locations

Locations (93)

M.D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

Cancer Therapy Centre at Campbelltown Hospital; 🇦🇺 Campbelltown, New South Wales, Australia

Radiation Oncology Victoria; 🇦🇺 East Melbourne, Victoria, Australia

Ziekenhuis Netwerk Antwerpen Middelheim; 🇧🇪 Antwerpen, Belgium

Universiteit Gent; 🇧🇪 Ghent, Belgium

Hopital de Jolimont; 🇧🇪 Haine Saint Paul, Belgium

Cazk Groeninghe - Campus Maria's Voorzienigheid; 🇧🇪 Kortrijk, Belgium

Clinique Saint-Joseph; 🇧🇪 Liege, Belgium

Clinique Sainte Elisabeth; 🇧🇪 Namur, Belgium

Instituto Nacional de Cancer; 🇧🇷 Copacabana, Rio de Janeiro, Brazil

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