Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
NCT01212718
Last updated date
ABOUT THIS STUDY
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.
Study Location
Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
Ulm, , , Germany
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase QuantitationResponse Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
NCT01212718
- Ulm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | 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:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
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| 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 |
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| 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 | |||