Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	70 and under	Other	FRE-IGR-PCI-99 EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004, NCT00005062

Objectives

1. 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.
2. Evaluate the quality of life and late sequelae in this patient population treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically proven limited stage small cell lung cancer



• Complete response to induction therapy (at least on chest x-ray)



• Normal brain CT scan or MRI less than 1 month prior to study



• No metastases (including ipsilateral lung metastases and malignant pleural effusion)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No concurrent chemotherapy

Endocrine therapy:

• Concurrent steroids allowed

Radiotherapy:

• Concurrent thoracic radiotherapy allowed

Surgery:

• Not specified

Other

• No other concurrent antitumoral agent

Patient Characteristics:

Age:

• 70 and under

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No prior cerebrovascular disease

Other:

• No epilepsy requiring permanent oral medication
• No other prior malignancy except skin cancer or carcinoma in situ of the cervix

Expected Enrollment

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

Outcomes

Incidence of brain metastases 2 years after randomization

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

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.

Le Péchoux C, Dunant A, Senan S, et al.: Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol 10 (5): 467-74, 2009.[PUBMED Abstract]

Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

Trial Contact Information

Trial Lead Organizations

Institut Gustave Roussy

Cecile Le Pechoux, MD, Study coordinator		Ph: 33-1-42-114-757

European Organization for Research and Treatment of Cancer

Suresh Senan, Study coordinator		Ph: 31-20-444-0414

Registry Information
Official Title		A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders
Trial Start Date		1999-09-15
Registered in ClinicalTrials.gov		NCT00005062
Date Submitted to PDQ		2000-02-11
Information Last Verified		2006-01-05

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