Clinical trial · Interventional
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases
Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases. PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indinavir sulfate | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| ritonavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Time to treatment failure in the brain (TTF) as determined by the radiological response rate
- measure
- Overall survival (OS)
- measure
- Radiological volumetric response to treatment
- measure
- Local intracranial disease progression at 4 months
- measure
- Progression-free survival at 6 months
Secondary outcomes (4)
- measure
- Improvement of symptoms
- measure
- Time to symptom relapse or symptom progression
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available