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Trial record 1 of 1 for:    NCT01212718
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Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase (FOGT5)

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ClinicalTrials.gov Identifier: NCT01212718
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : October 1, 2010
Sponsor:
Collaborators:
Pfizer, Berlin Germany
Medac, Hamburg, Germany
Study Group Oncology of Gastrointestinal Tumors (FOGT)
Information provided by:
University of Ulm

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE October 1, 2010
Last Update Posted Date October 1, 2010
Study Start Date  ICMJE July 2001
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
Best response to first-line chemotherapy (recist) [ Time Frame: 1 year ]
Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
overall survival, toxicity, treatment related complications, time to progression [ Time Frame: 3-year ]
See above.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Official Title  ICMJE Stratified and Randomized Multi-center Phase II - to Determine Potential Benefit of Treating Patients With Advanced Colorectal Cancer According to the Intratumoral TS RNA Levels
Brief Summary The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.
Detailed Description Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral relative TS mRNA expression levels were determined using samples shipped in RNA-preserving solution or as glass slides after microdissection of tumor cells. An independent company stratified the patients according to ther relative TS mRNA expression level in TS low and TS high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Non Resectable Metastasis
  • Reference Lesion
  • Biopsy
  • Thymidylate Synthase Quantitation
Intervention  ICMJE
  • Drug: FUFA
    2600/500 mg/m2 i.v. 24 h via port, 1 time weekly for six weeks, than have a break for 2 weeks (=8 weeks for 1 cycle)
  • Drug: systemic chemotherapy
    CPT-11, 80 mg/m2 for 90 minutes and 5 FU/FA 2000/500 mg/m2 iv. 24h via port; 1 time weekly for six weeks, than have a break for 2 weeks
Study Arms  ICMJE
  • Active Comparator: 5-FU
    FUFA 5-flurouracil and folinic acid control
    Intervention: Drug: FUFA
  • Active Comparator: Folfiri
    5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
    Intervention: Drug: systemic chemotherapy
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2010)
168
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients (>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy
  • a performance status WHO 0-2 (Karnofsky >= 60%)
  • an estimated life expectancy of at least 3 months
  • written informed consent

Exclusion Criteria:

  • patients older than 75 years not fulfilling these criteria
  • brain metastases or a secondary cane
  • a history of a systemic palliative chemotherapy
  • and an adjuvant chemotherapy (within 6 months)
  • pregnant or nursing women
  • a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical
  • laboratory and social conditions not allowing chemotherapy and follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01212718
Other Study ID Numbers  ICMJE FOGT5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Marko Kornmann, University of Ulm
Study Sponsor  ICMJE University of Ulm
Collaborators  ICMJE
  • Pfizer, Berlin Germany
  • Medac, Hamburg, Germany
  • Study Group Oncology of Gastrointestinal Tumors (FOGT)
Investigators  ICMJE Not Provided
PRS Account University of Ulm
Verification Date September 2010

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