Clinical trial · Interventional
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
NCT01104350CI-TRIAL-00104780completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external radiation therapy with gemcitabine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy and Concurrent Gemcitabine Chemotherapy
- description
- This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.
- interventionNames
- Other: external radiation therapy with gemcitabine
Primary outcomes (1)
- measure
- To determine the dose limiting toxicity and establish the maximal tolerated dose
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To determine the complete response rate of the primary tumor
- timeFrame
- 4-6 weeks following consolidation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0). * Karnofsky Performance Scale (KPS) ≥ 70% * Age ≥18 years old * Adequately functioning bladder, defined as continent and without the need for an indwelling catheter * Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN * Adequate renal function: calculated creatinine clearance \> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance * Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy. * Patients must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status. * Previous pelvic radiation therapy * Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible) * Prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles * Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis) * Women who are pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.