Clinical trial · Interventional
Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma
A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lomustine | Drug | Lomustine | ALIAS |
| procarbazine hydrochloride | Drug | Procarbazine | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (5)
- measure
- Progression-free survival at 12 weeks (Arm II)
- measure
- Toxicity
- measure
- Overall survival
- measure
- Quality of life as measured by EORTC QLQ-C30 and BTM
- measure
- Cost effectiveness
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma * WHO grade III or IV at diagnosis or relapse * Must have undergone primary therapy including radiotherapy * Must be in first recurrence confirmed by CT scan or MRI * Evaluable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-3 Life expectancy * At least 1 month Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Total and direct bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 3 times ULN * Alkaline phosphatase less than 2 times ULN Renal * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent serious illness * Considered fit to receive chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for glioma Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 2 months since prior radiotherapy * No prior radiosurgery, interstitial radiotherapy, or brachytherapy for glioma Surgery * Prior debulking surgery for recurrent disease allowed
References
Publications (1)
- RESULTBrada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM. Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. J Clin Oncol. 2010 Oct 20;28(30):4601-8. doi: 10.1200/JCO.2009.27.1932. Epub 2010 Sep 20. PMID 20855843