The aim of the PELICAN trial is to investigate the survival benefit of RFA followed by chemotherapy as compared to standard palliative chemotherapy alone in patients with LAPC.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
survival (in months)
Secondary outcome
Clinical: complications, toxicity of pre- and post-randomization chemotherapy,
VAS pain score
Pathophysiological: objective tumor reponse, progression free survival, CA 19-9
& CEA response, immunomodulation
Additional: quality of life, indirect and direct health costs
Background summary
Pancreatic cancer is the fifth leading cause of cancer-related death in the
Netherlands. Each year around 900 patients in the Netherlands are diagnosed
with *irresectable locally advanced pancreatic cancer* (LAPC) (i.e. without
distant metastases). The median survival is only approximately 5-6 months and
treatment options are limited, which moreover give only a minimal survival
benefit. The current standard treatment in the Netherlands is palliative
chemotherapy, which prolongs survival with only 2 to 3 months in most
patients.
Radiofrequency ablation (RFA) is a new therapy for LAPC that may prolong
survival. This technique involves the implantation of one or more electrodes
directly into the tumor to inflict thermal damage using heat. RFA is widely
used for cancer in other organs such as liver and prostate. Previous studies
have demonstrated RFA to be feasible and safe in patients with LAPC and have
shown an improvement of postoperative pain and survival rates of up to 12
months. These were however non-randomized studies with probable selection bias.
We have recently conducted two experimental studies and an observational phase
II safety study in patients with LAPC and have confirmed RFA to be feasible and
safe in these patients. In order to study the true effect of RFA in LAPC we
designed the Dutch nationwide PELICAN trial.
Study objective
The aim of the PELICAN trial is to investigate the survival benefit of RFA
followed by chemotherapy as compared to standard palliative chemotherapy alone
in patients with LAPC.
Study design
A total of 212 patients with LAPC without distant metastases after 2 months of
induction chemotherapy (i.e FOLFIRINOX or gemcitabine depending on WHO
performance status and age), recruited in 16 centres of the Dutch Pancreatic
Cancer Group, will be randomized for A) RFA followed chemotherapy or B)
chemotherapy only. Both groups undergo a 1.5 years follow-up.
Intervention
Radiofrequency ablation, which is performed through a median laparotomy
Study burden and risks
The operation to perform RFA and hospitalization will be a big burden for the
patient in the treatment group. Tumor tissue will also be taken from them
during the RFA procedure as well as extra blood samples during hospitalization.
The control group will only be treated with chemotherapy, which is standard
care. All included patients will be checked at the outpatient clinic at 3, 6,
12 and 18 months after the start of treatment, during which patients have to
fill in quality of life questionnaires and physical examination, blood tests
and additional diagnostic tests are being performed if necessary.
Complications that may occur are bleeding (mainly during operation),
pancreatitis, pancreatic fistula, ulcera of the duodenum or a portal vein
thrombosis
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2.
Locally irresectable tumor (see Appendix 1 of the protocol for criteria) 3.
Primary tumor 4. Stable disease or partial respons after 2 months of induction
chemotherapy (according to RECIST) 5. Fit for chemotherapy as assessed by the
medical oncologist plus: • Absolute neutrophil count >= 1.5 × 10^9/L • Platelet
count >= 100 × 10^9/L • Renal function: creatinine clearance > 50 ml/min •
Transaminases <= 3 x ULN 6. Fit for surgery assessed by the treating surgeon and
anesthesiologist 7. RFA technical feasible (see Appendix 2 of the protocol for
criteria) 8. Written informed consent 9. Age >= 18 years
Exclusion criteria
1. WHO performance status 3 or 4 2. Distant metastases on abdominal or thoracic
CT scan* 3. Previous surgical, local ablative or radiotherapy for pancreatic
cancer or chemotherapy which is inconsistent with the prescribed induction
schedule according to protocol** 4. Stenosis of > 50% of the hepatic artery AND
portal vein/ superior mesenteric vein 5. Second primary malignancy, except
adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix
uteri or other malignancies treated at least 5 years previously without signs
of recurrence. 6. Pregnancy * Positive or suspicious regional lymph node
metastases are not a reason for exclusion ** Surgical exploration is not a
contra-indication for inclusion kan zij
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 |
|---|---|
| CCMO | NL50467.018.14 |