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

Alternate Title

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	Not specified	NCI	RTOG-0212 RTOG 0212, NCT00057746

Objectives

1. Compare the incidence of brain metastases in patients with limited stage small cell lung cancer treated with different regimens of prophylactic cranial irradiation. (phase III closed to accrual as of 12/31/05)
2. Compare the overall and disease-free survival of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)
3. Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
4. Compare quality of life and late treatment sequelae of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
  • Limited stage (I-IIIB)
    • Confined to 1 hemithorax
    • No T4 or N3 disease



• Complete response after induction chemotherapy (with or without thoracic radiotherapy)



• Consolidative chest radiotherapy may be initiated before study



• No radiographic evidence of any of the following:
  • Brain metastases
    • Normal brain CT scan or MRI less than 1 month before study
  • Ipsilateral lung metastases
  • Malignant pleural effusion
    • Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 1 week since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
• Concurrent thoracic radiotherapy allowed

Surgery

• Not specified

Other

• No concurrent antitumor agents

Patient Characteristics:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 75,000/mm³
• Hemoglobin at least 10.0 g/dL

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Neurological function class 1 or 2
• No epilepsy requiring permanent oral medication
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other serious medical or psychiatric condition that would preclude study participation

Expected Enrollment

A total of 264 patients will be accrued for this study within 3.5 years.

Outcomes

Incidence of brain metastases (Phase III patients enrolled before 12/31/05)
Overall survival (Phase III patients enrolled before 12/31/05)
Disease-free survival (Phase III patients enrolled before 12/31/05)
Quality of life (Phase III patients enrolled before 12/31/05)
LENT-SOMA (Phase III patients enrolled before 12/31/05)
Incidence of chronic neurotoxicity (Phase II patients enrolled after 12/31/05)
Quality of life (Phase II patients enrolled after 12/31/05)

Incidence of chronic neurotoxicity (Phase II patients enrolled before 12/31/05)
Quality of life (Phase II patients enrolled before 12/31/05)

Outline

This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.



• Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.



• Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

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

Radiation Therapy Oncology Group

Aaron Wolfson, MD, Protocol chair		Ph: 305-243-4210 Email: awolfson@med.miami.edu

Registry Information
Official Title		A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
Trial Start Date		2003-02-19
Trial Completion Date		2009-08-12 (estimated)
Registered in ClinicalTrials.gov		NCT00057746
Date Submitted to PDQ		2002-10-28
Information Last Verified		2008-10-23
NCI Grant/Contract Number		CA21661

Back to Top