| CTRI Number |
CTRI/2019/09/021082 [Registered on: 05/09/2019] Trial Registered Prospectively |
| Last Modified On: |
30/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Sterotactic radiotherapy and chemotherapy to improve surgical resection and reduce recurrence |
|
Scientific Title of Study
|
Neoadjuvant treatment versus upfront surgery in Resectable
pancreatic cancer (NEVUS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reena Engineer |
| Designation |
Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Department of Radiation Oncology
11th Floor Room number 1124
Homibhaba building Dr Ernest Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820128662 |
| Fax |
|
| Email |
reena.engineer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akanksha Anup |
| Designation |
Junior Resident III |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Department of Radiation Oncology
Dr Ernest Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9890236460 |
| Fax |
|
| Email |
akkuanup27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Anup |
| Designation |
Junior Resident III |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Department of Radiation Oncology
Dr Ernest Borges Marg Parel Mumbai
Osmanabad
MAHARASHTRA
400012
India |
| Phone |
9890236460 |
| Fax |
|
| Email |
akkuanup27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funding by TRAC 3rd floor main building Dr Ernest Borges Marg Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Marg Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reena Engineer |
Tata Memorial Hospital |
Department of Radiation oncology 11th floor room number 1124 Dr Ernest Borges Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA |
9820128662
reena.engineer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arm A standard Arm Upfront surgery
|
Patients randomized to upfront surgery will undergo whipples procedure. vascular resection will be done if required.
|
| Intervention |
Arm B experimental Arm SBRT followed by 2 cycles of folfirinox |
Patients in the experimental arm after SBRT will received 2 cycles of modified folfirino post 1 to 2 weeks of SBRT fluorouracil (without bolus), leucovorin, irinotecan, and oxaliplatin.
Every cycle will be of 14 days Post 2 cycles of chemotherapy patient will be evaluated for surgery.
A cycle of m folfirino is delivered as follows oxaliplatin 85 mg per m2 IV over 2 hours on day 1, followed by irinotecan 180 mg per m2 IV over 90 minutes on day 1 followed by leucovorin 400 mg per m2 IV over 2 hours on day 1 followed by 5-FU 2400 mg per m2 IV over 46-48 hours.
Alternatively, leucovorin may be administered concurrently with the last 30 min of oxaliplatin, and the entire 90 minutes of irinotecan. 5-FU is administered via IV infusion only there is no bolus injection of 5-FU. White blood cell growth factor is required within 24 hours of completion of 5-FU, administered according to institutional procedures
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Radiologically defined to be resectable as per the NCCN guidelines Version 2 on a Triphasic CECT scan amenable to oncological surgical resection. Selected ampullary adenocarcinomas involving pancreatic head or abutting or involving vessels will be included.
-Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis
-No significant co-morbidities that would interfere with treatment and fit for general anaestheia
-Reliable for follow-up and signed informed consent.
-Karnofsky performance status (KPS) between 70 and 100.
-Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy.
|
|
| ExclusionCriteria |
| Details |
-Prior surgical resection of any pancreatic malignancy
-Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
-History of prior allergic reactions attributed to compounds of CT or MRI contrast
-Any prior therapy for pancreatic cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of margin negative resection, defined as the absence of viable tumor cells more than 1 mm from the inked surgical margin |
48 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Median overall survival
-Pathological response
-Incidence of 30 day post operative complications
-Radiological response per Response Evaluation by RECIST Loco-regional recurrence free survival, defined with follow-up radiological assessment.- Loco-regional recurrence free survival
|
48 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction :Stereotactic body radiotherapy is high precision radiotherapy where radiobiologically very high and efficient doses can be delivered. SBRT can be given over 5-10 days and the biologically equivalent dose appears to be higher than conventional fractionation schedules which is given over 5-6 weeks. This is also more convenient to patients and in case of resectable pancreatic cancer SBRT will not delay surgery significantly. May result in improved increased rates of R0 resection and hence may result in improved of local control and survivalStaging and baseline evaluation: - Baseline Triphasic CECT scan of the abdomen delineating the relation of the tumor with the vessels & the duodenum defined to be resectable as per the NCCN guidelines ( Version 2.0 )
- Baseline CEA ( Carcinoembryoinic antigen ) & CA-19.9( Carbohdrate antigen)
- CBC, LFT,RFT, total protein and albumin
Assessment of response to neoadjuvant therapy was based on Triphasic contrast enhanced restaging CT scans 6 weeks after completion of SBRT Treatment: Patients will undergo upfront surgery alone or SBRT followed by 2 cycles of chemotherapy and then surgery as per Institutional guidelines. Patients being randomized to upfront surgery arm (ARM A) will not require a tissue diagnosis, however histopathological confirmation would be required only if the tumor is not well appreciated or is considered doubtful as per the Triphasic CECT scan findings. A mandatory histological confirmation of adenocarcinoma pancreas would be required in experimental arm ( ARM B) prior to the start of therapy.Acute toxicity and adverse effects would be reported using the CTCAE VERSION 5(Appendix) recommendations for classifying acute toxic effects of radiotherapy 1) ARM A (Standard ARM) – Upfront surgery Patients randomized to upfront surgery will undergo Whipples procedure. Vascular resection will be done if required 2) ARM B (Experimental ARM) -SBRT followed by 2 cycles of FOLFIRINOX The following procedures would be done |