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


Phase 3
18 Years
N/A
Not Enrolling
Both
Tumors Metastatic to Brain

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The log-rank statistic will be used.

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Jonathan Knisely

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02461

NCT ID:

NCT00033254

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Tumors Metastatic to Brain
  • Neoplasm Metastasis

Name

Location

Radiation Therapy Oncology GroupPhiladelphia, Pennsylvania  19107