Monitoring patients with locally advanced rectal cancer after treatment
Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)
This study is looking at how well a "wait and watch" approach works for patients with locally advanced rectal cancer after their initial treatment, while tracking their health and quality of life over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06252142 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with locally advanced rectal cancer who have undergone neoadjuvant treatment and are suitable for a wait and watch approach. The study aims to monitor the patients' responses to treatment, track any side effects, and assess their quality of life using standardized questionnaires. Patients will be followed for at least two years post-treatment without any additional tests or hospital visits required. The goal is to gather data on the effectiveness of the wait and watch strategy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years diagnosed with locally advanced rectal cancer suitable for the wait and watch strategy.
Not a fit: Patients with non-adenocarcinoma types of rectal cancer or those not suitable for the wait and watch approach may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the wait and watch approach for patients with locally advanced rectal cancer.
How similar studies have performed: While the wait and watch approach has been utilized in clinical practice, this specific observational study aims to gather systematic data, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * Not eligible as per the above inclusion criteria
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial centre — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Rahul KRISHNATRY, MD — Tata Memorial Centre
- Study coordinator: Rahul Krishnatry, MD
- Email: krishnatry@gmail.com
- Phone: 022-24177000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.