Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Over 18	NCI	RTOG-BR-0118 RTOG-DEV-1006, NCT00033254

Objectives

1. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
2. Compare the time to tumor progression in patients treated with these regimens.
3. Compare the time to neuro-cognitive progression in patients treated with these regimens.
4. Compare the cause of death distribution in patients treated with these regimens.
5. Compare the frequency of toxic effects of these regimens in these patients.
6. Evaluate and compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed extracranial primary malignancy
• Multiple brain metastases
• At least 1 measurable brain metastasis by MRI
  • More than 4.0 cm

    OR

  • Located in midbrain or brainstem (radiosurgery ineligible)

Prior/Concurrent Therapy:

Biologic therapy:

• No prior thalidomide

Chemotherapy:

• More than 2 weeks since prior chemotherapy
• Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to the head or neck
• No prior radiosurgery

Surgery:

• Prior resection of brain metastases allowed

Other:

• No concurrent anticoagulant therapy

Patient Characteristics:

Age:

• Over 18

Performance status:

• Zubrod 0-1

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 11 g/dL*
• Hematocrit at least 35%*

 [Note: * Transfusion and/or epoetin alfa allowed]

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• ALT no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL
• BUN no greater than 25 mg/dL

Cardiovascular:

• No history of deep venous thrombosis

Other:

• No sensory neuropathy grade 2 or greater
• No known AIDS
• No other major medical illness or psychiatric impairments that would preclude study therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study

Expected Enrollment

A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.

Outline

This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
• Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily. Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Corn BW, Moughan J, Knisely JP, et al.: Prospective evaluation of quality of life and neurocognitive effects in patients with multiple brain metastases receiving whole-brain radiotherapy with or without thalidomide on Radiation Therapy Oncology Group (RTOG) trial 0118. Int J Radiat Oncol Biol Phys 71 (1): 71-8, 2008.[PUBMED Abstract]

Knisely JP, Berkey B, Chakravarti A, et al.: A phase III study of conventional radiation therapy plus thalidomide versus conventional radiation therapy for multiple brain metastases (RTOG 0118). Int J Radiat Oncol Biol Phys 71 (1): 79-86, 2008.[PUBMED Abstract]

Knisely JPS, Berkey BA, Chakravarti A, et al.: RTOG 0118: a phase III study of conventional radiation therapy alone vs. conventional radiation therapy plus thalidomide for multiple brain metastases. [Abstract] J Clin Oncol 23 (Suppl 16): A-1500, 114s, 2005.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Jonathan Knisely, MD, FRCPC, Protocol chair		Ph: 203-785-2960; 866-925-3226 Email: jonathan.knisely@yale.edu

Registry Information
Official Title		A Phase III Study Of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy For Multiple Brain Metastases
Trial Start Date		2002-06-10
Trial Completion Date		2008-05-01
Registered in ClinicalTrials.gov		NCT00033254
Date Submitted to PDQ		2002-02-05
Information Last Verified		2004-06-17
NCI Grant/Contract Number		CA21661

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