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CTRI Number  CTRI/2023/11/059575 [Registered on: 06/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [chemotherapy]  
Study Design  Single Arm Study 
Public Title of Study   Determining the efficacy and safety of neoadjuvant IP chemotherapy in rectal cancer patients with the spread of disease in peritoneum 
Scientific Title of Study   Bidirectional intraperitoneal chemotherapy along with systemic chemotherapy in adenocarcinoma of rectum with isolated peritoneal metastasis a prospective study 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Avanish Saklani 
Designation  Professor & Colorectal Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Department of Surgical Oncology tata memorial hospital dr ernest Borges marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avanish Saklani 
Designation  Professor & Colorectal Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Department of Surgical Oncology tata memorial hospital dr ernest Borges marg parel mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avanish Saklani 
Designation  Professor & Colorectal Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Colorectal Division, Department of Surgical Oncology Tata Memorial Hospital parel Mumbai
Professor and Chief,Division of Colorectal services,Department of Surgical Oncology, Tata Memorial Hospital,Dr Ernest Borges Street,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital,Department of Surgical Oncology, Dr. ernest Borges Marg Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Tata memorial hospital Parel, Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avanish Saklani  Tata Memorial Centre  Professor and Chief,Division of Colorectal services,Department of Surgical oncology,Homi Bhabha Building 12th Floor,Room No.1212 Tata Memorial Hospital,Dr. Ernest Borges Street,Parel,Mumbai And ACTREC Kharghar Navi Mumbai Contact: +91 22 2417 7000 Ext. 7176
Mumbai
MAHARASHTRA 		 7400319886

asaklani@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial centre Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Study Agent IP Paclitaxel + mFOLFIRI   IP chemotherapy Flemings 1 stage design 10 patients 4 should have response 20 mg per m2 once in 2 weeks 10 patients 4 should have response 40 mg per m2 once in 2 weeks 10 patients 4 should have response 60 mg per once in 2 weeks Cumulative Gr3 and 4 toxicity more than 70 percent at 2 months in any of the arms Lead to termination of the arm and previous arm will be taken Paclitaxel 20 to 60 mg per m2 4 cycles every 2 weekly given Systemic chemotherapy 4 cycles of 2 weekly mFOLFIRI.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Biopsy proven adenocarcinoma rectum
2 Needing laparoscopy (for staging/diversion stoma and/or ovarian transposition prior to cancer directed therapy.
3 PCI > 12 on staging laparoscopy
4 Planned for chemotherapy and reassess for curative treatment in MDJC
5 ECOG performance status < 2
6 Patient who can give informed consent for the study.
7 Patient does not have any contraindications to receive chemotherapy
8 Adequate haematological, hepatic and renal function parameters
9 haematological- Hb> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.
11 Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT/ALP ≤2. 5 x ULN, S. albumin ≥ 30 g/L.
12 Renal function- Creatinine ≤ 1.5 ULN or Creatinine clearance ≥ 40 mL/min.
13 Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. 
 
ExclusionCriteria 
Details  Extraperitoneal metastasis based on imaging or biopsy.
Patients undergoing upfront definitive resection of primary
History of abdominal tuberculosis, significant adhesions in abdomen secondary to previous
laparotomy or any other benign pathology
Gross ascites, extensive small bowel involvement
Known hypersensitivity against 5-FU, capecitabine, leucovorin, irinotecan
Known contraindications against 5-FU, leucovorin, capecitabine, irinotecan
Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA
III-IV, LVEF<50%.
Baseline neuropathy > NCI Grade I
Chronic inflammatory bowel disease
On-treatment participation in another clinical study in the period 30 days prior to inclusion and
during the study.
Subject pregnant or breast feeding or planning to become pregnant within 6 months.
History of cancer diagnosis in the past 5 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Response rates – Proportion of patients having more than 50% PCI reduction  36 months 
 
Secondary Outcome  
Outcome  TimePoints 
Conversion to negative peritoneal cytology
Complete cytoreduction rates, Grade 3/4 toxicity rates, DFS, OS.
 		 36 months 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 2 
Date of First Enrollment (India)   13/11/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This is a study that will be conducted in rectal cancer patients with distant disease spread to involve peritoneum only. This study will be done for determining the efficacy and safety of intraperitoneal chemotherapy which is delivered directly into the peritoneum i.e the abdominal cavity along with intravenous chemotherapy in rectal cancer patients with peritoneal metastasis.

A total of 92 patients will be enrolled into the study over a period of 3 years. The study will be conducted in 2 phases. The first phase will enroll 10 patients each into the different dosage schedules of intraperitoneal chemotherapy with paclitaxel to find the safe dose of drug to be administered. Then in the next phase total of 72 patients will be evaluated (including 10 patients from the first phase) to look at the efficacy of the intraperitoneal chemotherapy dose that came out to be safe from the first phase of the study.

Patients aged more than 18 years who are diagnosed with confirmed rectal cancer and having evidence of peritoneal disease on staging evaluation will be considered for screening and inclusion into the study. The patients will first undergo a staginglaproscopy procedure to calculate the involvement of peritoneum by cancer by an index called PCI. If the PCI is more than 12 the patients will be screened for eligibility as per the study inclusion and exclusion criteria. After written informed consent the patients will then receive treatment with combined intraperitoneal chemotherapy with a  drug called Paclitaxel and intravenous chemotherapy with a regime called FOLFIRI, both given at 2 weekly intervals. The response to treatment will be then assessed by repeat staging laproscopy procedure done at 8 weeks. The response rates, toxicity rates and survival benefits of the treatment will be estimated at the completion of study recruitment.

 
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