Clinical TrialID 7241
Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer
NCT00506155
Bladder Cancer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7241
- Evidence Id
- 7241
- Core Evidence Id
- 7241
- Source Clinical Trial Id
- 7231
- Herb2 Clinical Trial Id
- HBCT007231
- Nct Id
- NCT00506155
- Title
- Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Bladder Cancer
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Avastin|DRUG: Cisplatin|DRUG: Doxorubicin|DRUG: Methotrexate|DRUG: Vinblastine Sulfate
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 60
- Outcome Measure
- Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen, Number of participants out of total with a response defined as "downstaging" to \<= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of "TNM"; T describes size tumor \& cancer spread into nearby tissue; N describes spread to nearby lymph nodes; \& M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment., Following 20 weeks of chemotherapy
- Sponsor Collaborator
- M.D. Anderson Cancer Center|Genentech, Inc.
- Funded By
- OTHER
- Location
- UT MD Anderson Cancer Center, Houston, Texas, 77030, United States
- Other Id
- 2006-0620
- Start Date
- 2007-06
- Primary Completion Date
- 2014-08
- Completion Date
- 2014-08
- First Posted
- 2007-07-25
- Results First Posted
- 2016-03-31
- Last Update Posted
- 2016-03-31
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00506155
- Title Cn
- Title En
- Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer
- Bilingual Status
- semi_complete