Evaluation of the effect of neoadjuvant chemotherapy and chemoradiotherapy in patients with Borderline pancreatic cancer and non-metastatic unresectable
pancreatic cancer in achieving negative surgical margin
Design
clinical trial Phase 2 on 18 patients without control group
Settings and conduct
Patients referred to the Firoozgar Hospital Radiotherapy or Surgery Clinic, who are classified according to the NCCN Criteria, to borderline and non-metastatic unresectable pancreatic cancer. Liver and kidney functional test and Alb, CEA, CA19-9, CBC DIFF will be taken. They are treated with mFOLFIRINOX regimes and then after two to four weeks, patients undergoing chemoradiotherapy with mXELOX. Thereafter, after 4-6 weeks they undergo a CT scan and are evaluated by a team of surgeons and radiation oncologists to assess resectability. If patients do not have a metastasis and the tumor is resectable, surgery would be performed and surgical margins would be evaluated.
Participants/Inclusion and exclusion criteria
Patients over the age of 18 to 75 years who have not previously received chemotherapy or radiotherapy in the upper abdomen, as well as the functional status of group 0 or one according to the ECOG Criteria.
Patients should have acceptable results from the initial tests that show organ function, as follows: .AST, ALT <2ULN .BILI <20 .INR NL. Cr NL WBC> 3000 .Hb> 9 .Platelet> 100,000.
Intervention groups
Radiotherapy is performed in 3D Conformal. And with a daily dose of 1.8 Gy to a total dose of 45 Gy in 25 fraction five days a week to the GTV area combind with mXELOX chemotherapy regimes .
Main outcome variables
negative surgical margin in patients with pancreatic cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170306032913N5
Registration date:2020-09-14, 1399/06/24
Registration timing:registered_while_recruiting
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Alireza Nikoofar
Name of organization / entity
Firoozgar Clinical Research Development Center (FCRDC)
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1743
Email address
nikoofar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effectiveness of neoadjuvant chemoradiation in patient with borderline and unresectable pancreatic cancer
Public title
the effectiveness of neoadjuvant chemoradiation in patient with pancreatic cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18 to 75 years who have not previously received chemotherapy or radiotherapy in the upper abdomen, ,
acceptable liver, kidney, and lung function, and acceptable CBC diff
the functional status of group 0 or one according to the ECOG definition.
Patient with borderline and unresectable nonmetastatic pancreatic cancer
Exclusion criteria:
Serious concomitant systemic disorder
Women with a positive pregnancy test or lactating
Previously radiotherapy of upper abdomen
Have endocrine pancreatic tumors or ampullary cancer
Pathology other than pancreatic adenocarcinoma
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
initial chemotherapy with mfolfirinox regimes then chemoradiation with capox regimes and then if not metastatic referred to surgery and the end evaluation of negative margins of surgery
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran international committee for ethics biomedical research
Street address
behafarin st.karim khan st,valiasr square,tehran,
City
tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.IUMS.FMD.REC.1399.133
Health conditions studied
1
Description of health condition studied
Pancreatic cancer
ICD-10 code
C25
ICD-10 code description
Malignant neoplasm of pancreas
Primary outcomes
1
Description
the rate of negative surgical margin
Timepoint
the end of neoadjuvant therapy
Method of measurement
pathological evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: MFOLFIRINOX chemotherapy regimens (Oxalipaltin 85mg / m2 — leucovorin calcium 400mg / m2— Irinotecan 150 mg / m2 --- Fluorouracil 2400mg / m2 continous infusion over 46h are treated then under CT Simmulation after two to four weeks. Radiotherapy is given to patients in supine position without oral and intravenous contrast with a thickness of three millimetres, GTV is contouring with radiation oncologist according to the RTOG protocol, and radiotherapy is performed as 3D Conformal radiotherapy. The GTV includes a tumor seen on a CT scan, and the CTV includes tumor with a margin of 1.5 cm. Patients' lymph nodes are not treated electives. Patients are treated by a physics and radiation oncologist team, and patients are treated for 5 weeks 5 days a week at a daily dose of 1.8 Gy to a total dose of 45 GHz. They are visited twice a week by a doctor and are treated with mXELOX regimes during radiotherapy according to the following protocol; cap capecitabin 625mg/m2 BID and oxaliplatin injection drug at a dosage of 65 mg / m2 from the first day of radiotherapy weekly for two weeks followed by a week of rest and then weekly for two weeks.