To examine combination @entity900 and twice-daily accelerated irradiation ( @entity138 ) after aggressive transurethral resection of @entity150 (TURBT) in an attempt to preserve the bladder and to determine the likelihood that @entity1 who complete this regimen could then complete three cycles of @entity1499 , @entity900 , @entity5713 (MCV) chemotherapy. Between 1998 and 2000, 52 @entity1 with Stage T2-T4aN0M0 disease, from 17 institutions, were entered into the trial. Forty-seven @entity1 were deemed eligible; the planned accrual was 40. Of the 46 @entity1 , 68% were >60 years old, 70% were @entity1 , and 96% had a Karnofsky score >/=90. The clinical T stage was T2 in 66%, T3a in 25%, and T3b in 9%. The median follow-up at the time of analysis was 26 months. The protocol required TURBT within 6 weeks of the initiation of induction therapy. Induction treatment involved 13 days of concomitant boost @entity138 , 1.8 Gy to the pelvis in the morning followed by 1.6 Gy to the @entity5 4-6 h later. For sensitization, @entity900 (20 mg/m(2)) was given on the first 3 days of each treatment week. Three to four weeks after induction, @entity1 were evaluated cystoscopically for @entity66 . @entity1 whose biopsies and cytologic evaluations showed no disease completed consolidation chemoirradiation. @entity1 with @entity41 went on to cystectomy. After either consolidation or cystectomy, @entity1 were to complete three cycles of MCV chemotherapy. Of the 47 @entity1 , 45% completed all phases of the protocol treatment with minor, or no, deviations. Five @entity1 refused either the postinduction evaluation or cystectomy and 6 refused adjuvant chemotherapy. The CR rate after induction therapy was 74%. For 2 @entity1 , @entity66 after induction was limited to positive cytologic findings, and for 8 @entity1 , biopsy of the primary site revealed persistence. Of the 8 cystectomy @entity1 , 2 had no evidence of disease in the bladder at pathologic review of the surgery specimen. Grade 3 @entity137 related to chemotherapy was observed in 11% of @entity1 during both induction and consolidation, and in 41% during adjuvant chemotherapy. A total of 8 @entity1 (36% of those receiving adjuvant chemotherapy) went on to develop Grade 4 @entity1398 or @entity882 during additional adjuvant chemotherapy. Grade 3 @entity137 due to @entity138 was seen in 4% and 0% of @entity1 during induction and consolidation, respectively. One @entity1 developed Grade 4 @entity3041 during consolidation. The projected 36-month value for locoregional failure, distant metastasis, overall survival, and bladder-intact survival was 27%, 29%, 61%, and 48%, respectively. After aggressive TURBT, twice-daily accelerated @entity138 initiated in concomitant-boost format is well tolerated and results in a rate of complete response (74%) similar to that in previous bladder-sparing trials. The projected 2-year values for locoregional control, bladder-intact survival, and overall survival were also consistent with previously reported trials of bladder-sparing treatment. With only 45% of @entity1 completing three cycles of MCV, this form of adjuvant chemotherapy appears to be poorly tolerated by most @entity1 .

RTOG 97-06: initial report of a phase I-II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with XXXX , and adjuvant MCV combination chemotherapy.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'men'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity66 :: ('MESH:D004194', 'Disease') :: ['residual disease'] @entity41 :: ('MESH:D018365', 'Disease') :: ['residual tumor'] @entity138 :: ('MESH:C563738', 'Disease') :: ['RT'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity3041 :: ('MESH:D006869', 'Disease') :: ['hydronephrosis'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity150 :: ('MESH:D001749', 'Disease') :: ['bladder tumor'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate'] @entity5713 :: ('MESH:D014747', 'Chemical') :: ['vinblastine']
@entity900 :: (MESH:D002945,Chemical) :: ['cisplatin']
