Study for Wait and Watch Suitable in Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rectal Neoplasms. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)
Overview
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.
Primary outcome measures
- 1. Successful organ preservation rate [Time frame: 3 years.]
- European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal) [Time frame: 3 years]
- European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer) [Time frame: 3 years]
- European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health) [Time frame: 3 years]
- European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis). [Time frame: 3 yeasrs]
- European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy). [Time frame: 3 years]
- Low Anterior Resection Syndrome Score (LARS) [Time frame: 3 years]
- International Prostate Symptom Score (IPSS) [Time frame: 3 years]
Secondary outcome measures (8)
- Local regrowth rates [Time frame: 3 years]
- Total Mesorectal Excision rates [Time frame: 3 years]
- Loco-regional control [Time frame: 3 Years]
- Disease-free survival [Time frame: 3 Years]
- Overall survival. [Time frame: 3 years.]
- Colostomy-free survival. [Time frame: 3 years]
- Total Mesorectal Excision free survival [Time frame: 3 years]
- Treatment-related toxicities [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
India · 1 center
- Tata Memorial centre — Mumbai
Identifiers
NCT: NCT06252142 · 4307