Clinical trial · Interventional
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
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
NCT01212718CI-TRIAL-00003981FOGT5completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Resectable Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Reference Lesion | — | UNRESOLVED | — |
| Thymidylate Synthase Quantitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FUFA | Drug | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5-FU
- description
- FUFA 5-flurouracil and folinic acid control
- interventionNames
- Drug: FUFA
- type
- ACTIVE_COMPARATOR
- label
- Folfiri
- description
- 5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
- interventionNames
- Drug: systemic chemotherapy
Primary outcomes (1)
- measure
- Best response to first-line chemotherapy (recist)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.