Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

NCT01212718 | Completed Phase 2 DMC

• 1 other identifier: FOGT5
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Non Resectable Metastasis; Reference Lesion; Biopsy; Thymidylate Synthase Quantitation

Keywords

Colorectal Cancer; non resectable metastasis; reference lesion; biopsy; thymidylate synthase quantitation

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

• overall survival, toxicity, treatment related complications, time to progression

  3-year

Study Arms (2)

5-FU

ACTIVE COMPARATOR

FUFA 5-flurouracil and folinic acid control

Drug: FUFA

Folfiri

ACTIVE COMPARATOR

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

Drug: systemic chemotherapy

Interventions

FUFA DRUG

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)

5-FU

systemic chemotherapy DRUG

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

Folfiri

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead
• Pfizer, Berlin Germany: collaborator
• Medac, Hamburg, Germany: collaborator
• Study Group Oncology of Gastrointestinal Tumors (FOGT): collaborator

Study Sites (1)

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

Ulm, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: October 1, 2010
• Study Start: July 1, 2001
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

DE (1)