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 (NCT) | NCT00786058 |
| Protocol serial number | German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 427; CONKO-003 |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funders | Amgen GmbH (Germany), Medac (Germany), Ribosepharm GmbH (Germany), Sanofi-Aventis Deutschland GmbH (Germany) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, open, multicentre, randomised, controlled phase III trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Oxaliplatin, folinic acid, 5-fluorouracil |
| Primary outcome measure(s) |
Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS). |
| Key secondary outcome measure(s) |
1. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/04/2021: Publication references and ClinicalTrials.gov number added.
