Oxaliplatin/folinic acid/5-fluorouracil (24-hour) (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer
| ISRCTN | ISRCTN52780546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52780546 |
| ClinicalTrials.gov number | NCT00786058 |
| Secondary identifying numbers | German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 427; CONKO-003 |
- Submission date
- 24/07/2007
- Registration date
- 21/12/2007
- Last edited
- 08/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helmut Oettle
Scientific
Scientific
Augustenburger Platz 1
Berlin
13344
Germany
| Phone | +49 (0)30 450 553 222 |
|---|---|
| helmut.oettle@charite.de |
Study information
| Study design | Prospective, open, multicentre, randomised, controlled phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Oxaliplatin/folinic acid/5-fluorouracil (24-hour) (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer |
| Study objectives | Study hypothesis: To test the hypothesis that second-line chemotherapy with OFF improves overall survival compared to best supportive care alone. Amendment 1: To test the hypothesis that second-line chemotherapy with OFF improves overall survival compared to folinic acid/5-fluorouracil (24-hour) and best supportive care alone (FF). |
| Ethics approval(s) | Approval received from the Ethikkommission der Charite Universitatsmedizin Berlin on the 14th October 2002 (ref: 192/2002); amendment 1 approved on 12th December 2003. |
| Health condition(s) or problem(s) studied | Pancreatic cancer |
| Intervention | After stratification for duration of first line therapy, Karnofsky Performance Status (KPS) and tumour stage, patients were randomised and treated with 5-fluorouracil (FU) 2 g/m^2 (24-hour)/folinic acid (FA) 200 mg/m^2 (FF) on days 1, 8, 15 and 22 with or without oxaliplatin 85 mg/m^2 (2-hour) on days 8 and 22. Therapy paused on days 23 to 42. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Oxaliplatin, folinic acid, 5-fluorouracil |
| Primary outcome measure | Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS). |
| Secondary outcome measures | 1. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission 2. Toxicity: NCI Common Toxicity Criteria (CTC) grade differentation, description with tabulations 3. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS) |
| Overall study start date | 01/01/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 165 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Histologically or cytologically proven advanced pancreatic cancer after confirmed failure of treatment with gemcitabine 2. No more than three weeks between confirmed failure of treatment with gemcitabine and start of second-line therapy 3. Karnofsky performance status greater than 70% 4. Measurable disease of more than 15 x 15 mm per computed tomography (CT) or magnetic resonance (MR) scan 5. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L 6. Written informed consent 7. Age of 18 years or more 8. Sufficient contraception up to three months after the end of therapy |
| Key exclusion criteria | 1. Active infection (as decided by physician) 2. Pregnant or breastfeeding women 3. Psychiatric disorders 4. Heavy disorders, contradictory with study (as decided by physician) 5. Heavy complications of the tumour, requiring an acute therapy 6. Heavy cardiac disorders 7. Peripheral, sensory and/or motor neuropathy (greater than II° - grade of sensoric/motoric toxicity regarding National Cancer Institute [NCI] criteria) 8. Hyperesthesia against study medication or related drugs 9. Patients with renal failure (creatinine clearance less than 30 ml/min) |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Augustenburger Platz 1
Berlin
13344
Germany
13344
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
Augustenburger Platz 1
Berlin
13344
Germany
| Phone | +49 (0)30 450 553 222 |
|---|---|
| lars.roll@charite.de | |
| Website | http://www.charite.de/de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Industry
Amgen GmbH (Germany)
No information available
Medac (Germany)
No information available
Ribosepharm GmbH (Germany)
No information available
Sanofi-Aventis Deutschland GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2005 | 08/04/2021 | Yes | No | |
| Results article | 10/08/2014 | 08/04/2021 | Yes | No |
Editorial Notes
08/04/2021: Publication references and ClinicalTrials.gov number added.
