Back to resultsImage-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Primary Purpose
Bladder Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
external radiation therapy with gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
Eligibility 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
Sites / Locations
- Memorial Sloan Kettering at Basking Ridge
- Memorial Sloan Kettering Cancer Center @ Suffolk
- Memorial Sloan Kettering Westchester
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering at Mercy Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy and Concurrent Gemcitabine Chemotherapy
Arm 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.
Outcomes
Primary Outcome Measures
To determine the dose limiting toxicity and establish the maximal tolerated dose
Secondary Outcome Measures
To determine the complete response rate of the primary tumor
To determine the long term toxicity
Full Information
NCT ID
NCT01104350
First Posted
April 14, 2010
Last Updated
May 30, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01104350
Brief Title
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Official Title
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy and Concurrent Gemcitabine Chemotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
external radiation therapy with gemcitabine
Intervention Description
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)
Primary Outcome Measure Information:
Title
To determine the dose limiting toxicity and establish the maximal tolerated dose
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the complete response rate of the primary tumor
Time Frame
4-6 weeks following consolidation therapy
Title
To determine the long term toxicity
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Kollmeier, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
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