Study for Wait and Watch Suitable in Rectal Cancer (ARROW)

Tata Memorial Centre

Status

Enrolling

Conditions

Rectal Neoplasms

Treatments

Other: Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose

Study type

Observational

Funder types

Other

Identifiers

NCT06252142

4307

Details and patient eligibility

About

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.

Full description

The standard treatment options offered to patients of locally advanced rectal cancer are neoadjuvant (treatment given before surgery), radiotherapy & chemotherapy, followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the watch and wait or non-operative management is an option. In this, the patient is monitored after treatment completion. In this study, investigators will only 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. The patient will be followed up, as per standard follow-up protocol, for at least two years after the completion of their treatment.

Enrollment

260 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.