SWOG clinical trial number
4B951
MVAC in Organ-Confined Bladder Cancer Based on p53 Status
Closed
Phase
Published
Abbreviated Title
Local Bladder
Activated
10/15/2001
Closed
03/28/2006
Participants
Research committees
Genitourinary Cancer
Treatment
Cisplatin
Doxorubicin
Methotrexate
Vinblastine Sulfate
MVAC
Eligibility Criteria Expand/Collapse
NOTE: This protocol requires pre-authorization of patient registration from USC. Please see Appendix F of the protocol and start the process at least one week prior to the expected date of registration.
Pts who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy must have TCC; pathologic stage of P1, P2a, P2b, N0, M0 or TCC Pa, P0 or PIS, N0, M0 w/clincial stage TCC T1, T2a or T2b based on TURBT. Pts must not have rec'd any systemic chemo w/in 5 yrs of reg nor prior systemic chemo for bladder ca. Pts must not have rec'd any pelvic RT. Pts must be registered w/in 9 weeks from the date of surgery. Pts must have a PS of 0-1 following cystectomy. Pts must have chest x-ray showing no evidence of met disease w/in 6 wks prior to, or following cystectomy. Pts must have a lymph node dissection of >/= 15 LN, or if fewer, a CT of abd/pelvis. Pt must have post-op WBC >/= 4000, PLTs >/= 150,000, serum creatinine < / = 1.8 mg/dl, or following measured 24-hour Cr Cl > / = 50 cc/min, SGOT or SGPT & Alk Phos < / = 2 x IULN, Bili w/in IULN. Pt must have EKG w/in 6 wks prior to or following cystecomy.
Pts who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy must have TCC; pathologic stage of P1, P2a, P2b, N0, M0 or TCC Pa, P0 or PIS, N0, M0 w/clincial stage TCC T1, T2a or T2b based on TURBT. Pts must not have rec'd any systemic chemo w/in 5 yrs of reg nor prior systemic chemo for bladder ca. Pts must not have rec'd any pelvic RT. Pts must be registered w/in 9 weeks from the date of surgery. Pts must have a PS of 0-1 following cystectomy. Pts must have chest x-ray showing no evidence of met disease w/in 6 wks prior to, or following cystectomy. Pts must have a lymph node dissection of >/= 15 LN, or if fewer, a CT of abd/pelvis. Pt must have post-op WBC >/= 4000, PLTs >/= 150,000, serum creatinine < / = 1.8 mg/dl, or following measured 24-hour Cr Cl > / = 50 cc/min, SGOT or SGPT & Alk Phos < / = 2 x IULN, Bili w/in IULN. Pt must have EKG w/in 6 wks prior to or following cystecomy.
Publication Information Expand/Collapse
2015
PMid: PMID25873574 | PMC number: PMC4602027
PMid: PMID25413313 | PMC number: PMC4524781
2011
A phase III study of molecularly targeted adjuvant therapy in locally advanced urothelial cancer of the bladder based on p53 status [PMID21810677; PMC3164246]
2010
Cell cycle regulatory protein alterations in a randomized clinical trial of adjuvant chemotherapy following radical cystectomy and pelvic lymphadenectomy
2009
Variability in surgical quality in a randomized clinical trial of adjuvant chemotherapy following radical cystectomy and pelvic lymphadenectomy
2008
Results of the p53 targeted therapy trial for patients with organ confined node negative bladder cancer treated with radical cystectomy
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