Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years 2. Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines [3,1] 3. Biopsy-proven adenocarcinoma (non-signet or non-mucinous) 4. T1-4a or N0-2, plus or minus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ) 5. Non-circumferential disease with CCL less than 7 cm Lower – mid rectum starting upto 7 cm from Anal verge 6. Previously treated with the intent of wait-and-watch with TNT with or without brachytherapy and completed TNT part of treatment (for retrospective cohort) 7. Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered 8. Consent to be on standard regular follow-up and answer quality of life questionnaires
Exclusion criteria
Exclusion criteria: Not eligible as per the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Successful organ preservation rate: percentage of patients avoiding surgery at a median follow up of 3 years 2. Quality of life outcomes: scored as per standard EORTC manual for various questionnaires. Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Colostomy-free survival: From the date of start of treatment till the date of permanent colostomy procedure.Timepoint: 3 years;Disease-free survival: From the date of start of treatment till the date of diagnosis of disease progression at any siteTimepoint: 3 years;Local regrowth rates: Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical responseTimepoint: 3 years;Loco-regional control: From the date of start of treatment till the date of local regrowthTimepoint: 3 years;Overall survival: From the date of start of treatment till the date of death (any cause)Timepoint: 3 years;Total Mesorectal Excision free survival:From the date of start of treatment till the date of TME-based surgeryTimepoint: 3 years;Total Mesorectal Excision rates: Percentage of patients requiring TME-based surgical management.Timepoint: 3 years;Treatment-related toxicities: Acute and late treatment-related Gastro Intestinal, Genito Urinary or any other CTCAE toxicities of grade 3 or higherTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr Rahul Krishnatry
Tata Memorial Hospital
Outcome results
None listed