Clinical trial · Interventional
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)
NCT00004259CI-TRIAL-00040547completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCNU 150mg/m2 | Drug | Carmustine | ALIAS |
| BCNU 200mg/m2 | Drug | Carmustine | ALIAS |
| BCNU 80mg/m2 | Drug | Carmustine | ALIAS |
| CCNU | Drug | Lomustine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| TMZ 150mg/m2 six 6-week cycles | Drug | — | UNRESOLVED |
| TMZ 150mg/m2 six 8-week cycles | Drug | — | UNRESOLVED |
| TMZ 200mg/m2 | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Radiation therapy + temozolomide (TMZ)
- description
- Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
- interventionNames
- Drug: TMZ 200mg/m2
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- RT + BCNU/CCNU
- description
- Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
- interventionNames
- Drug: BCNU 80mg/m2
- Radiation: radiation therapy
- Drug: CCNU
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following:
* Anaplastic astrocytoma
* Mixed oligodendroglial/astrocytic tumors
* Oligodendroglial component must be no greater than 25%
* No vascular proliferation and necrosis
* Increased cellularity, pleomorphism, and nuclear atypia allowed
* No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
* Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible
* Study therapy must begin within 6 weeks of diagnosis
* No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
* Pathologic evidence of local meningeal infiltration by underlying tumor allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 1 year
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Blood urea nitrogen no greater than 25 mg/dL
* Creatinine less than 1.5 times normal
Pulmonary:
* No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or lomustine or completion of therapy
Other:
* No other major medical illness or psychiatric impairment that would preclude study compliance
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No known hypersensitivity to 1 of the components of carmustine, lomustine, temozolomide, dacarbazine, or any other nitrosourea
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to brain or head and neck
Surgery:
* Not specified
Other:
* No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detectedReferences
Publications (1)
- RESULTChang SM, Seiferheld W, Curran W, Share R, Atkins J, Choucair A, Kresl J, Thoron L, Cairncross G, Gilbert M, Bahary JP, Dolinskas C, Louis DN, Bushunow P, Buckner J, Barger G, Mehta M. Phase I study pilot arms of radiotherapy and carmustine with temozolomide for anaplastic astrocytoma (Radiation Therapy Oncology Group 9813): implications for studies testing initial treatment of brain tumors. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1122-6. doi: 10.1016/j.ijrobp.2004.01.002. PMID 15234047