| CTRI Number |
CTRI/2024/11/076321 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised controlled trial in advanced carcinoma of ovary using intraoperative normothermic chemotherapy |
|
Scientific Title of Study
|
Normothermic intraperitoneal intraoperative chemotherapy following Interval Cytoreductive Surgery in Advanced CA Ovary (Stage IIIC) - A randomised controlled study (NICOR trial) |
| Trial Acronym |
NICOR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upasana Baruah |
| Designation |
Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Gynaecologic oncology
Dr. B. Borooah Cancer Institute Gopinath Nagar
Dr. B. Borooah Cancer Institute Gopinath Nagar
Kamrup
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
|
| Email |
drupasanabaruah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Upasana Baruah |
| Designation |
Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Gynaecologic oncology
Dr. B. Borooah Cancer Institute Gopinath Nagar
Dr. B. Borooah Cancer Institute Gopinath Nagar
Kamrup
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
|
| Email |
drupasanabaruah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Upasana Baruah |
| Designation |
Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Gynaecologic oncology
Dr. B. Borooah Cancer Institute Gopinath Nagar
Dr. B. Borooah Cancer Institute Gopinath Nagar
Kamrup
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
|
| Email |
drupasanabaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
| TRAC(Tata memorial centre Research and Administrative council, Tata memorial hospital,Jerbai Wadia Rd, Dadar east Parel, Mumbai,Maharashtra,PIN 400014,India |
|
|
Primary Sponsor
|
| Name |
BBCIDr B Borooah Cancer Institute |
| Address |
Dr B Borooah cancer Institute,Gopinath Nagar, AK azad road, Guwahati, Assam, 781016, India. |
| 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 |
| Dr Upasana Baruah |
Dr B Borooah Cancer Institute |
Room no 17, ground floor, OPD building, Dr. B. Borooah Cancer Institute Gopinath Nagar, AK azad road, Guwahati, 781016
Kamrup
ASSAM |
08812828202
drupasanabaruah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee BBCI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cisplatin 75mg/m2 intraperitoneally (IP) |
Intraoperative NIPEC protocol (ONLY Arm A) will consist of cisplatin 75mg/m2 intraperitoneally (IP), which will be instilled with the help of intraabdominal drains placed inside the abdomen. Drains will be unclamped after 24 hours for any unabsorbed fluid to be removed.
Due to increased chances of hypokalaemia and hypomagnesaemia, preloading with potassium chloride and magnesium sulphate will be done. Adequate fluid hydration will be maintained. Antiemetics will be given for control of emesis associated with cisplatin. Vitals monitoring every 4-6 hours will be done. Correction of dyselectrolytemia will be done. Monitoring of adverse effects will be done and recorded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5. The total duration of intervention will be 24 hours |
| Comparator Agent |
Neoadjuvant chemotherapy ONLY and Surgery Interval Cytoreductive |
Patients in the control group will ONLY receive the standard care, which consists of surgery (ICS) with Neoadjuvant chemotherapy (NACT).
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1) 20 years to 70 years.
2) Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma).
3) Pre-therapy FIGO (International Federation of Gynaecology and Obstetrics) stage IIIC (clinical).
4) Patient eligible for Interval Cytoreductive Surgery (ICS) after neo-adjuvant chemotherapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks.
5) WHO (World Health Organization) performance status less than 2.
6) Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery.
7) Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products.
8) Patient is willing to participate and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
9) Signed written informed consent.
10) Residual disease after surgery (cytoreduction score CC) CC 0 (no macroscopic residue) or CC 1
11) Per-operative haemorrhage less than2 L
12) Diuresis maintained during surgery, without oliguria or anuria . |
|
| ExclusionCriteria |
| Details |
1) Benign disease, borderline disease, non-epithelial ovarian carcinoma or carcinosarcoma.
2) Decompensated liver disease.
3) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
4) Auditory impairment
5) Disease that contraindicates hyper hydration (including cardio-respiratory disease).
6) Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhoea) chronic disease.
7) Any unresolved NCI-CTCAE grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia).
8) Concomitant treatment with prophylactic phenytoin.
9) Bowel resection anastomosis.
10) Receipt of live attenuated vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment).
11) Pregnant or breast feeding woman.
12) Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent.
13) Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons).
14) Person under guardianship.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) Progression-free Survival (PFS) [Time frame: from randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 2 years. (Follow-up up to 5 years)] |
1) Progression-free Survival (PFS) will be assessed at baseline, 1 year and 2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival [Time Frame: From date of randomization to the date of death or date of last follow up]. |
2 years follow up will be done for OS |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Advanced epithelial ovarian cancer has a
poor prognosis. Surgery after a few courses of chemotherapy or primary surgery
followed by chemotherapy is the standard of care for these patients. However, despite
good response after surgery and chemotherapy disease returns in most patients
within 1-2 years. This signifies the inherent unfavourable nature of the advanced
disease. Various studies were done with the aim of improving the survival of
such patients. One of the approach is to directly instill chemotherapy into the
abdomen during surgery which is called intraperitoneal chemotherapy. In
addition, early postoperative intraperitoneal chemotherapy also known as EPIC
has certain conceptual benefits, as it is applied shortly after cytoreductive
surgery when the tumour burden is minimal, uneven drug distribution is reduced
as the adhesions are not formed and there prevention of entrapment of residual
cancer cells in postoperative fibrin deposits. Traditionally EPIC is
administered in the postoperative period, usually between days 1 to 5, through
both an inflow and outflow drains inserted during surgery. We will be giving
chemotherapy inside the abdomen immediately after completion of surgery and
will be kept for 24 hours. After 24 hours excess fluid will be removed by the
intraabdominal drains.
Methodology
(procedure):
Patients with advanced Ca Ovary stage IIIC will be included in the study. Informed consent will be taken from every patient.
After adequate surgery cisplatin chemotherapy will be instilled intraperitoneal
chemotherapy with the help of intraabdominal drains placed inside the abdomen. Drains will be
unclamped later for any unabsorbed fluid to be removed. Preloading with potassium chloride and magnesium sulphate will be given to avoid side effects.
Adequate fluid hydration will be maintained. Antiemetics( to prevent vomiting) will be provided for control of emesis associated
with cisplatin. Monitoring and correction of dyselectrolytemia will be done.
Monitoring of adverse effects will be done and recorded as per existing
guidelines. |