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Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.


- candidate number21774
- NTR NumberNTR5084
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2015
- Secondary IDsClinicalTrials.gov NCT02292745
- Public TitleEfficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
- Scientific TitleAddition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasibility.
- ACRONYMLAPC-1
- hypothesisCombining FOLFIRINOX chemotherapy and stereotactic radiotherapy can lead to better regional tumor control and better overall survival in patients with locally advanced pancreatic cancer.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, FOLFIRINOX, Stereotactic radiotherapy
- Inclusion criteria- Cytological or histologically confirmation of pancreatic cancer.
- WHO performance status of 0 or 1
- ASA classification I or II
- Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy.
- No evidence of metastatic disease
- Largest tumor diameter < 7 cm x 7 cm x 7 cm
- Normal renal function (Creatinine ≥ 30 ml/min).
- Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
- Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l)
- Age > 18 years and < 75 years
- Written informed consent
- Exclusion criteria- Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
- Lymph node metastases from primary tumor outside the field of radiation.
- Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence.
- Pregnancy, breast feeding.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-nov-2020
- Target number of participants51
- Interventionsstereotactic radiotherapy
- Primary outcome- overall survival
- Secondary outcome- number of toxicity events related to chemotherapy
- radiological response after chemotherapy and radiotherapy
- number of resections at end of stereotactic radiotherapy
- time to locoregional disease progression
- time to development of distant metastases
- predictive value of a set of biological markers for treatment response (miRNAs)
- Timepoints- Pre-treatment evaluation (pre-screening)
- screening
- Initial visit to the outpatient clinic (baseline)
- FOLFIRINOX treatment period, consisting of the following visits:
Cycle 1 (week 2)
Cycle 2 (week 4)
Cycle 3 (week 6)
Cycle 4 (week 8)
CT Evaluation (week 9)
Cycle 5 (week 10)
Cycle 6 (week 12)
Cycle 7 (week 14)
Cycle 8 (week 16)
CT evaluation (week 17)
- Stereotactic radiation pre-treatment visit (only for non-metastatic patients) (week 18)
- Stereotactic radiation treatment period (dosing days 1,2,3,4 and 5, week 20)
- Follow up period consisting of the following visits: FU visit 1: 6 weeks after RT (week 26)
FU visit 2: 3 months after RT (week 32)
FU visit 3: 6 months after RT (week 46)
FU visit 4: 9 months after RT (week 58)
FU visit 5: 12 months after RT (week 70)
FU visit 6: 15 months after RT (week 82)
FU visit 7: 18 months after RT (week 94)
FU visit 8: 21 months after RT (week 106)
FU visit 9: 24 months after RT (week 118)
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESProf. dr. C.H.J. van Eijck
- CONTACT for SCIENTIFIC QUERIESProf. dr. C.H.J. van Eijck
- Sponsor/Initiator Foundation for Liver and Gastrointestinal Research
- Funding
(Source(s) of Monetary or Material Support)
Foundation for Liver and Gastrointestinal Research
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-mrt-2015 - 25-apr-2015


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