The safety and efficacy of a new chemoradiation approach to treating bladder cancer, which is designed to effect a cure while conserving the organ, is being evaluated in RTOG 95-06, a phase I/II clinical trial. Patients with T2 to T4a muscle-invading bladder cancer are eligible for the study. Thirty patients are to be evaluated.
All patients undergo transurethral surgery followed 3 to 4 weeks later with CFI (cisplatin, fluorouracil(Drug information on fluorouracil), irradiation). Cisplatin(Drug information on cisplatin) (15 mg/m²) and 5-FU (400 mg/m²) are given on days 1,2,3 and 15,16,17 of induction treatment. Pelvic irradiation (3Gy, twice a day with 4 hours in between) is given on days 1,3,15 and 17. Each patient is then reevaluated by cystoscopy and rebiopsy in the eighth week of treatment.
If there is not complete remission of the tumor (rebiopsy is positive) following the induction treatment, and the patient is operable, then a radical cystectomy is done.
If the tumor has responded completely (or if the patient is inoperable), then the patient continues with consolidation CFI. This treatment regimen includes: cisplatin (15 mg/m²) and 5-FU (400 mg/m²) on days 1,2 and 3 in the ninth week of treatment. The bladder is treated with 2.5 Gy twice a day with 4 hours in between on days 1 and 3.
The chemotherapy and radiation therapy schedule is repeated 2 weeks later.
The RTOG study is based on a pilot study by the University of Paris Group at Hopital Necker, said Dr. William U. Shipley, chair of the RTOG study. The complete response rate at the University of Paris was 70%, which is very encouraging, Dr. Shipley noted.
"We had difficulty accruing patients and completing protocol treatment to RTOG 89-03" [a precursor to the present study], said Dr. Shipley. "This protocol will likely be better tolerated by the patient, the chemotherapy is done on an outpatient basis, and the decision as to whether the bladder is responding to the chemoradiation treatments is made earlier," he said.
"We hope all these factors will make it easier for the patients and for the clinicians to use this protocol to safely select a bladder-preserving treatment if the tumor is responding," Dr. Shipley said.