No registrations found.
ID
Source
Brief title
Health condition
locally advanced pancreatic cancer
pancreatic neoplasm
FOLFIRINOX
stereotactic radiotherapy
Sponsors and support
Intervention
Outcome measures
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)
Study objective
Combining FOLFIRINOX chemotherapy and stereotactic radiotherapy can lead to better regional tumor control and better overall survival in patients with locally advanced pancreatic cancer.
Study design
- 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)
Intervention
stereotactic radiotherapy
C.H.J.
van Eijck
C.H.J.
van Eijck
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4812 |
| NTR-old | NTR5084 |
| Other | NCT02292745 : ClinicalTrials.gov |