Clinical trial NCT06252142: Study for Wait and Watch Suitable in Rectal Cancer
Official title: Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Neoplasms
Keywords: Rectal Cancer
Wait and Watch
SCRT
LCRT
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally Advanced Rectal Cancer Patients.

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, 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 1. Successful organ preservation rate
timeFrame: 3 years.
measure: European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal)
timeFrame: 3 years
measure: European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer)
timeFrame: 3 years
measure: European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health)
timeFrame: 3 years
measure: European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis).
timeFrame: 3 yeasrs
measure: European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy).
timeFrame: 3 years
measure: Low Anterior Resection Syndrome Score (LARS)
timeFrame: 3 years
measure: International Prostate Symptom Score (IPSS)
timeFrame: 3 years
Secondary outcomes:
measure: Local regrowth rates
timeFrame: 3 years
measure: Total Mesorectal Excision rates
timeFrame: 3 years
measure: Loco-regional control
timeFrame: 3 Years
measure: Disease-free survival
timeFrame: 3 Years
measure: Overall survival.
timeFrame: 3 years.
measure: Colostomy-free survival.
timeFrame: 3 years
measure: Total Mesorectal Excision free survival
timeFrame: 3 years
measure: Treatment-related toxicities
timeFrame: 3 years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial centre
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Rahul KRISHNATRY, MD
role: PRINCIPAL_INVESTIGATOR
References: