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
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Other: external radiation therapy with gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the dose limiting toxicity and establish the maximal tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104350

Contacts
Contact: Marisa Kollmeier, MD 212-639-3952
Contact: Dean Bajorin, MD 646-422-4333

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Marisa Kollmeier, MD    212-639-3952      
Contact: Dean Bajorin, MD    646-422-4333      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Marisa Kollmeier, MD    212-639-3952      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Marisa Kollmeier, MD    212-639-3952      
Contact: Dean Bajorin, MD    646-422-4333      
Principal Investigator: Marisa Kollmeier, MD         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Marisa Kollmeier, MD    212-639-3952      
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Marisa Kollmeier, MD    212-639-3952      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Marisa Kollmeier, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01104350     History of Changes
Other Study ID Numbers: 10-031
Study First Received: April 14, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Bladder
Radiotherapy
Gemcitabine
Chemotherapy
10-031

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 22, 2014