Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01104350
First received: April 14, 2010
Last updated: May 19, 2014
Last verified: May 2014

April 14, 2010
May 19, 2014
April 2010
April 2017   (final data collection date for primary outcome measure)
To determine the dose limiting toxicity and establish the maximal tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104350 on ClinicalTrials.gov Archive Site
  • To determine the complete response rate of the primary tumor [ Time Frame: 4-6 weeks following consolidation therapy ] [ Designated as safety issue: No ]
  • To determine the long term toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
Other: external radiation therapy with gemcitabine

All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement.

  • Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy)
  • Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy)
  • Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)
Experimental: Radiotherapy and Concurrent Gemcitabine Chemotherapy
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.
Intervention: Other: external radiation therapy with gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
April 2017
April 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marisa Kollmeier, MD 212-639-3952
Contact: Dean Bajorin, MD 646-422-4333
United States
 
NCT01104350
10-031
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Marisa Kollmeier, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP