Study for Wait and Watch Suitable in Rectal Cancer

Study acronym: ARROW
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated April 10, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Enrollment target: 75 to 260
    • Interventions: Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose (Other) to not stated
    • Eligibility criteria expanded, about 27 words
    • Study arms: 0 to 4
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 19, 2026 to Feb 2026
    • Study completion date: Feb 19, 2028 to Jun 2026
    • Start date changed from estimate of Feb 19, 2024 to Apr 1, 2024
    • Study description expanded, about 104 words
  4. Primary endpoints: 2 to 8
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study title revised
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06252142
Lead Sponsor Tata Memorial Centre
Conditions
(from sponsor)		 Rectal Neoplasms
Related terms Rectal Neoplasms
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov