Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase (FOGT5)

This study has been completed.
Sponsor:
Collaborators:
Pfizer, Berlin Germany
Medac, Hamburg, Germany
Study Group Oncology of Gastrointestinal Tumors (FOGT)
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01212718
First received: September 9, 2010
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Non Resectable Metastasis
Reference Lesion
Biopsy
Thymidylate Synthase Quantitation
Drug: FUFA
Drug: systemic chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Best response to first-line chemotherapy (recist) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).


Secondary Outcome Measures:
  • overall survival, toxicity, treatment related complications, time to progression [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    See above.


Enrollment: 168
Study Start Date: July 2001
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5-FU
FUFA 5-flurouracil and folinic acid control
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)
Active Comparator: Folfiri
5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01212718

Locations
Germany
Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
Ulm, Germany
Sponsors and Collaborators
University of Ulm
Pfizer, Berlin Germany
Medac, Hamburg, Germany
Study Group Oncology of Gastrointestinal Tumors (FOGT)
  More Information

No publications provided

Responsible Party: Prof. Dr. Marko Kornmann, University of Ulm
ClinicalTrials.gov Identifier: NCT01212718     History of Changes
Other Study ID Numbers: FOGT5
Study First Received: September 9, 2010
Last Updated: September 30, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
Colorectal Cancer
non resectable metastasis
reference lesion
biopsy
thymidylate synthase quantitation

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014