| CTRI Number |
CTRI/2024/02/062583 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational Study for Locally Advanced
Rectal Cancer Patients Suitable for Wait and Watch
Treated with Total Neoadjuvant Therapy |
|
Scientific Title of Study
|
Ambispective Observational Study for Locally Advanced
Rectal Cancer Patients Suitable for Wait and Watch
Treated with Total Neoadjuvant Therapy (ARROW) |
| Trial Acronym |
ARROW |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Krishnatry |
| Designation |
Professor (F) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Krishnatry |
| Designation |
Professor (F) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Krishnatry |
| Designation |
Professor (F) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai Maharashtra India 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 |
| Dr Rahul Krishnatry |
Tata Memorial Hospital |
Department of Radiation Oncology F, 11 floor, room no: 1125, Homi Bhabha Block, Parel
Mumbai
MAHARASHTRA |
02224177028
krishnatry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines [3,1]
3. Biopsy-proven adenocarcinoma (non-signet or non-mucinous)
4. T1-4a or N0-2, plus or minus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)
5. Non-circumferential disease with CCL less than 7 cm
Lower – mid rectum starting upto 7 cm from Anal verge
6. Previously treated with the intent of wait-and-watch with TNT with or without brachytherapy and completed TNT part of treatment (for retrospective cohort)
7. Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered
8. Consent to be on standard regular follow-up and answer quality of life questionnaires
|
|
| ExclusionCriteria |
| Details |
Not eligible as per the above inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Successful organ preservation rate: percentage of patients avoiding surgery at a median
follow up of 3 years
2. Quality of life outcomes: scored as per standard EORTC manual for various questionnaires.
|
3 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Local regrowth rates: Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response |
3 years |
| Total Mesorectal Excision rates: Percentage of patients requiring TME-based surgical management. |
3 years |
| Loco-regional control: From the date of start of treatment till the date of local regrowth |
3 years |
| Disease-free survival: From the date of start of treatment till the date of diagnosis of disease progression at any site |
3 years |
| Overall survival: From the date of start of treatment till the date of death (any cause) |
3 years |
Colostomy-free survival: From the date of start of treatment till the date of permanent
colostomy procedure. |
3 years |
| Total Mesorectal Excision free survival:From the date of start of treatment till the date of TME-based surgery |
3 years |
| Treatment-related toxicities: Acute and late treatment-related Gastro Intestinal, Genito Urinary or any other CTCAE toxicities of grade 3 or higher |
3 years |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
23/02/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy & chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, we are only going to observe the patient’s response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment. |