Colorectal CancerPhase 2FOGT5NCT01212718
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
A Phase 2 study testing FUFA and systemic chemotherapy in people with Colorectal Cancer and Non Resectable Metastasis, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Non Resectable Metastasis, Reference Lesion
- What is being tested?
- FUFA and systemic chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2001to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
Ulm
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation
- Being tested
- FUFA, systemic chemotherapy
- Keywords
- Colorectal Cancer, non resectable metastasis, reference lesion, biopsy, thymidylate synthase quantitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUFADrug
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)
systemic chemotherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 5-FU | Active comparator | FUFA 5-flurouracil and folinic acid control Receives: Drug: FUFA |
| Folfiri | Active comparator | 5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm Receives: Drug: systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
overall survival, toxicity, treatment related complications, time to progression
See above.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startJul 2001
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Berlin Germany, Medac, Hamburg, Germany, Study Group Oncology of Gastrointestinal Tumors (FOGT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212718
- Sponsor's protocol ID
- FOGT5
- Acronym
- FOGT5
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01212718
- Acronym / sponsor ID
- FOGT5 / FOGT5
- Conditions
- Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation
- Keywords
- Colorectal Cancer, non resectable metastasis, reference lesion, biopsy, thymidylate synthase quantitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Pfizer, Berlin Germany, Medac, Hamburg, Germany, Study Group Oncology of Gastrointestinal Tumors (FOGT)
- Study start
- Jul 2001
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-FU | Active comparator | Drug: FUFAFUFA 5-flurouracil and folinic acid control |
| Folfiri | Active comparator | Drug: systemic chemotherapy5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUFA2600/500 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) | Drug | 5-FU |
| systemic chemotherapyCPT-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 | Drug | Folfiri |
Primary outcome
Best response to first-line chemotherapy (recist)
Time frame: 1 year
Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
1 secondary outcome
overall survival, toxicity, treatment related complications, time to progression
Time frame: 3-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FUFA and systemic chemotherapy in people with Colorectal Cancer and Non Resectable Metastasis, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best response to first-line chemotherapy (recist) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2010.