Clinical trial · Interventional
Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas
A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas
- 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. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients with malignant gliomas.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Toxicity
- measure
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma * Supratentorial tumor * No well-differentiated astrocytoma or glioma with oligodendroglial component * No multifocal glioma * Has undergone surgery within the past 6 weeks * No recurrent glioblastoma multiforme PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Neurological functional status 0-2 * Life expectancy \> 12 weeks * ANC ≥ 1,200/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Blood urea nitrogen ≤ 1.5 times ULN * Total and direct bilirubin ≤ 3 times ULN * AST and ALT ≤ 3 times ULN * Alkaline phosphatase ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study completion * No other malignancies within the past 3 years, except for carcinoma in situ of the cervix or nonmelanoma skin cancer * No acquired immune deficiency syndrome (AIDS) * No major medical illness or psychiatric impairment that would preclude study compliance PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the head and neck * No other concurrent therapy for the tumor
References
Publications (0)
Data not yet available