Status:
UNKNOWN
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases
Lead Sponsor:
Oncology Institute of Southern Switzerland
Conditions:
Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not y...
Detailed Description
OBJECTIVES: * Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months treatment failure rate, in patients with brain metastases treated with external-beam radiotherapy i...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic cancer with brain metastases
- Biopsy of brain metastases is not required
- All cancer types allowed, except for the following:
- Prostatic adenocarcinoma
- Sarcoma
- Melanoma
- Germ cell carcinoma,
- Small-cell lung cancer
- Measurable disease by MRI of the brain
- Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)
- Life expectancy \> 4 months
- Able to understand the aim of trial and to comply with follow-up
- No HIV seropositivity
- PRIOR CONCURRENT THERAPY:
- Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy
- Not requiring cytotoxic treatment within 3 months after study radiotherapy
- At least 1 week since prior and no concurrent phenytoin
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00637637
Start Date
September 1 2007
Last Update
August 12 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
2
Oncology Institute of Southern Switzerland - Lugano
Lugano, Switzerland, CH-6900
3
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091