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

This study is currently recruiting participants.

Verified April 2013 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: April 25, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 14, 2010

Last Updated Date

April 25, 2013

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

April 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01104350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Bladder Cancer

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2017

Estimated Primary Completion Date

April 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01104350

Other Study ID Numbers ^ICMJE

10-031

Has Data Monitoring Committee

Not Provided

Responsible Party

Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marisa Kollmeier, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

April 2013

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

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