Expired Study
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Philadelphia, Pennsylvania 19103


Purpose:

Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.


Study summary:

OBJECTIVES: I. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide. II. Compare the time to tumor progression in patients treated with these regimens. III. Compare the time to neuro-cognitive progression in patients treated with these regimens. IV. Compare the cause of death distribution in patients treated with these regimens. V. Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens. 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. PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.


Criteria:

Inclusion Criteria: - Histologically confirmed extracranial primary malignancy - Multiple brain metastases - At least 1 measurable brain metastasis by MRI - More than 4.0 cm - Located in midbrain or brainstem (radiosurgery ineligible) - Performance status - Zubrod 0-1 - At least 8 weeks - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 11 g/dL* - Hematocrit at least 35%* - Bilirubin no greater than 1.5 mg/dL - ALT no greater than 2 times normal - Creatinine no greater than 1.5 mg/dL - BUN no greater than 25 mg/dL - No history of deep venous thrombosis - 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 - No prior thalidomide - 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) - See Disease Characteristics - No prior radiotherapy to the head or neck - No prior radiosurgery - Prior resection of brain metastases allowed - No concurrent anticoagulant therapy


Study is Available At:


Original ID:

NCI-2012-02461


NCT ID:

NCT00033254


Secondary ID:

RTOG-BR-0118


Study Acronym:


Brief Title:

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


Official Title:

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

332


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan Knisely
Principal Investigator
Radiation Therapy Oncology Group

Study Dates

Start Date:March 2002
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 5, 2013
First Received Date:April 9, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of life as measured by the SQLI
Time Frame:12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Time Frame:Up to 6 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Cause of death distribution
Time Frame:Up to 6 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
Time Frame:Up to 6 years
Safety Issues:False
Description:Cumulative incidence model will be used to analyze the data.
Outcome Type:Primary Outcome
Measure:Time to tumor progression
Time Frame:Date of randomization to documentation of progression, assessed up to 6 years
Safety Issues:False
Description:Cumulative incidence model will be used to analyze the data. A multivariate Cox model analysis will be performed.
Outcome Type:Primary Outcome
Measure:Overall survival
Time Frame:Up to 6 years
Safety Issues:False
Description:The log-rank statistic will be used.

Study Interventions

Intervention Type:Radiation
Name:radiation therapy
Description:Undergo conventional radiation therapy
Arm Name:Arm I (radiation therapy)
Other Name:irradiation
Intervention Type:Drug
Name:thalidomide
Description:Given orally
Arm Name:Arm II (radiation therapy, thalidomide)
Other Name:Kevadon
Intervention Type:Procedure
Name:quality-of-life assessment
Description:Ancillary studies
Arm Name:Arm I (radiation therapy)
Other Name:quality of life assessment

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm I (radiation therapy)
Description:Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
Study Arm Type:Experimental
Arm Name:Arm II (radiation therapy, thalidomide)
Description:Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation:Knisely JP, Berkey B, Chakravarti A, Yung AW, Curran Jr WJ, Robins HI, Movsas B, Brachman DG, Henderson RH, Mehta MP. 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. 2007 Dec 28; [Epub ahead of print]
PMID:18164847
Reference Type:Results Reference
Citation:Corn BW, Moughan J, Knisely JP, Fox SW, Chakravarti A, Yung WK, Curran WJ Jr, Robins HI, Brachman DG, Henderson RH, Mehta MP, Movsas B. 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. 2007 Dec 28; [Epub ahead of print]
PMID:18164829

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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