Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)

Status: Recruiting
Location: See location...
Study Type: Observational
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, investigators 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age more than 18 years.

• Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines \[3,1\]

• Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)

• Non-circumferential disease with CCL less than 7 cm

• Lower - mid rectum starting upto 7 cm from Anal verge

• Previously treated with the intent of wait-and-watch with TNT or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(for retrospective cohort).

• Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered

• Consent to be on standard regular follow-up and answer quality of life questionnaires

• Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate.

Locations
Other Locations
India
Tata Memorial centre
RECRUITING
Mumbai
Contact Information
Primary
Rahul Krishnatry, MD
krishnatry@gmail.com
022-24177000
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 260
Treatments
Retrospective LCRT
Retrospective SCRT
Prospective LCRT
Prospective SCRT
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov