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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best response to first-line chemotherapy (recist)

Outcome Description:

Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

FOGT5

NCT ID:

NCT01212718

Start Date:

July 2001

Completion Date:

September 2010

Related Keywords:

  • Colorectal Cancer
  • Non Resectable Metastasis
  • Reference Lesion
  • Biopsy
  • Thymidylate Synthase Quantitation
  • Colorectal Cancer
  • non resectable metastasis
  • reference lesion
  • biopsy
  • thymidylate synthase quantitation
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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