Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Arm A (RT, procarbazine, lomustine, vincristine)
  Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (RT, temozolomide)
  Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.

Geprüfte Regime

• concomitant temozolomide (TMZ):
  75 mg/m^2, orally daily
• radiotherapy
• procarbazine:
  Days 8-21: 60 mg/m^2 orally
• adjuvant temozolomide (TMZ):
  150 or 200 mg/m^2 orally
• CCNU:
  Day 1: 110 mg/m^2 orally
• vincristine:
  Days 8 and 29: 1.4 mg/m^2 IV

Quelle: ClinicalTrials.gov