New Chemoradiation Approach for Bladder Cancer Tested in RTOG 95-06

November 1, 1995

The safety and efficacy of a new chemoradiation approach to treating bladder cancer, which is designed to effect a cure while

The safety and efficacy of a new chemoradiation approach to treatingbladder cancer, which is designed to effect a cure while conservingthe organ, is being evaluated in RTOG 95-06, a phase I/II clinicaltrial. Patients with T2 to T4a muscle-invading bladder cancerare eligible for the study. Thirty patients are to be evaluated.

All patients undergo transurethral surgery followed 3 to 4 weekslater with CFI (cisplatin, fluorouracil, irradiation). Cisplatin(15 mg/m²) and 5-FU (400 mg/m²) are given on days 1,2,3and 15,16,17 of induction treatment. Pelvic irradiation (3Gy,twice a day with 4 hours in between) is given on days 1,3,15 and17. Each patient is then reevaluated by cystoscopy and rebiopsyin 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 treatmentregimen includes: cisplatin (15 mg/m²) and 5-FU (400 mg/m²)on days 1,2 and 3 in the ninth week of treatment. The bladderis treated with 2.5 Gy twice a day with 4 hours in between ondays 1 and 3.

The chemotherapy and radiation therapy schedule is repeated 2weeks later.

The RTOG study is based on a pilot study by the University ofParis Group at Hopital Necker, said Dr. William U. Shipley, chairof the RTOG study. The complete response rate at the Universityof Paris was 70%, which is very encouraging, Dr. Shipley noted.

"We had difficulty accruing patients and completing protocoltreatment to RTOG 89-03" [a precursor to the present study],said Dr. Shipley. "This protocol will likely be better toleratedby the patient, the chemotherapy is done on an outpatient basis,and the decision as to whether the bladder is responding to thechemoradiation treatments is made earlier," he said.

"We hope all these factors will make it easier for the patientsand for the clinicians to use this protocol to safely select abladder-preserving treatment if the tumor is responding,"Dr. Shipley said.