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Trial: NCT00003930 [RDF]

Label NCT00003930
Slug nct00003930
Trialid NCT00003930
Lookup name NCT00003930
Provenance http://clinicaltrials.gov/show/NCT00003930?displayxml=true
Lastchanged date October 13, 2015
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003930
Overall status Completed
Id info secondary id CDR0000067122
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 84
Number of arms 1
Is section 801 Yes
Is fda regulated Yes
Brief title Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Acronym
Official title A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
Study type Interventional
Id info nct alias
Completion date November 2013
Verification date October 2015
Why stopped
Id info org study id RTOG-9906
Required header url https://clinicaltrials.gov/show/NCT00003930
Study design Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Radiation Therapy Oncology Group
Primary completion date July 2003
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 1/Phase 2
Start date September 1999
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: - Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection. - Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population. - Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population. OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17. Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after evaluation, patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9, and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo a cystectomy. At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.
Condition browse 83a4296de97b4c648b4ab87333a66ba6
Intervention browse bf412e63e1a3db3e658edcd14f70917c
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 11bf869870d22a435e9c11237efaa9be
Oversight info United States: Federal Government (Oversight_info)
Eligibility 0cb13f1ee459c296b9a4127921c0ad10
Keywords stage II bladder cancer, stage III bladder cancer
Conditions Bladder Cancer
Locations 0011cbaa804b3207ef771c0af73016af, 042367f29d558bca743d07b3eaf99f17, 0480c1a356c5707fd3538e164d1df899 More →
Links None
Results references 84d85f844fc73dc4034124a0e36a28aa, PMID:19100600
Arm groups Arm 1 (Arm Group)
Location countries Canada, United States
Interventions cisplatin (Intervention), gemcitabine hydrochloride (Intervention), conventional surgery (Intervention), radiation therapy (Intervention), paclitaxel (Intervention)
Secondary outcomes 1ff0b1f8c7b8075101fa1739729e242f, 552832d4c2ab9804f0707a607446b2d9, 60394b0c1bf239e1e89c7f76d568782f, 9e4787d98dac0c893d658d72bd415bfa, bf325d78a4101d4eccb7cea44fc0712d
References 3b852a4eb3a101771c4277ad7b5139ca, PMID:19636019
Primary outcomes a9efdb0aaff3c2b4208015aa270a89c0
Removed countries None
Overall officials 4c2603f8c022c5587c185fbd49b7d619