search
Back to results

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

Primary Purpose

Colorectal Cancer, Non Resectable Metastasis, Reference Lesion

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
FUFA
systemic chemotherapy
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, non resectable metastasis, reference lesion, biopsy, thymidylate synthase quantitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5-FU

Folfiri

Arm Description

FUFA 5-flurouracil and folinic acid control

5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm

Outcomes

Primary Outcome Measures

Best response to first-line chemotherapy (recist)
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
See above.

Full Information

First Posted
September 9, 2010
Last Updated
September 30, 2010
Sponsor
University of Ulm
Collaborators
Pfizer, Berlin Germany, Medac, Hamburg, Germany, Study Group Oncology of Gastrointestinal Tumors (FOGT)
search

1. Study Identification

Unique Protocol Identification Number
NCT01212718
Brief Title
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Acronym
FOGT5
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Pfizer, Berlin Germany, Medac, Hamburg, Germany, Study Group Oncology of Gastrointestinal Tumors (FOGT)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation
Keywords
Colorectal Cancer, non resectable metastasis, reference lesion, biopsy, thymidylate synthase quantitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU
Arm Type
Active Comparator
Arm Description
FUFA 5-flurouracil and folinic acid control
Arm Title
Folfiri
Arm Type
Active Comparator
Arm Description
5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
Intervention Type
Drug
Intervention Name(s)
FUFA
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Best response to first-line chemotherapy (recist)
Description
Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
overall survival, toxicity, treatment related complications, time to progression
Description
See above.
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
City
Ulm
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

We'll reach out to this number within 24 hrs