Clinical Trial RTOG 0834
- Phase III trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup trial.
- Principal Investigator
- Priya Kumthekar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 0834
- The purpose of this study is to determine whether the addition of temozolomide treatment to radiotherapy or the addition of temozolomide treatment after completion of radiotherapy will improve the results of the treatment.
- Until recently, brain tumors (anaplastic gliomas) were treated with radiotherapy or with chemotherapy. Previous studies have shown an increased time to regrowth of the tumor but no gain in overall survival time by adding a combination of three chemotherapeutic drugs (procarbazine, lomustine [CCNU], and vincristine—also called PCV)— to radiotherapy. However, PCV chemotherapy causes side effects in many patients. In contrast, another study in a much more malignant brain tumor showed an improved outcome by adding temozolomide chemotherapy during and after radiation. These data are difficult to bring together and have led to patients with these tumors being treated differently at different institutions.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have newly diagnosed anaplastic glioma (brain tumor).
- Participants must not have had prior chemotherapy or radiotherapy to the brain.
- Description of Treatment
- Participants will be "randomized" into one of the study groups. Randomization means that participants are put into a group by chance. Neither the participants nor the study doctor can choose the placement of the groups. Participants in group 1 (also called “Arm 1”) will receive radiotherapy alone, with further treatment including chemotherapy if there is tumor growth. Radiotherapy will be delivered over 6-7 weeks. Participants in group 2 (also called “Arm 2”) will receive radiotherapy. In addition, from the first day of radiotherapy until the last day of radiation participants will take temozolomide orally once daily for a maximum of 7 weeks. Participants in group 3 (also called “Arm 3”) will receive radiotherapy. In addition, four weeks after the completion of radiotherapy, participants will receive temozolomide. Participants will take temozolomide once daily for 5 days, every 28 days for up to 12 cycles. This will be for about 12 months. Participants in group 4 (also called “Arm 4”) will receive radiotherapy. In addition, from the first day of radiotherapy until the last day of radiation participants will take temozolomide orally once daily for a maximum of 7 weeks. Four weeks after the completion of radiotherapy, participants will restart temozolomide. Participants will take temozolomide once daily for 5 days, every 28 days for up to 12 cycles. This will be for about 12 months.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Priya Kumthekar
- A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
- A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
- A Phase 1 Open-label, Multicenter Study To Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884), and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer
- Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma
- A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy
last updated: 02-May-16 12:54 AM
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