Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: NIL: NIL
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed diagnosis of adenocarcinoma of the rectum 2.Clinical stage T1-T4, N0-N2, M0 at diagnosis 3.ECOG Performance status 0-1 4.Neoadjuvant treatment with either short course or long course radiation therapy and / or chemotherapy 5.Complete or near complete clinical response after neoadjuvant therapy 6.Patients willing to be on watch-and-wait strategy. 7.The distance from anal verge of tumour up to 10 cm (Mid and low rectal tumours)
Exclusion criteria
Exclusion criteria: 1.Recurrent rectal cancer 2.Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study. 3.Not willing to consent for the study or to follow up routinely 4.Patients who cannot read or understand the language of QoL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the local regrowth rates at 2 years in Asian patients managed with the watch-and-wait strategy after neoadjuvant therapy in rectal cancer.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the rates of colostomy free survival at 2 years and 5 yearsTimepoint: 2 years;To determine the clinical complete response rates (cCR) and regrowth rates with respect to various neoadjuvant treatment approachesTimepoint: 2 years;To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.Timepoint: 2 years;To determine compliance of these patients to recommended surveillance protocol.Timepoint: 5 years;To determine the rates of overall survival (OS) at 2 years and 5 yearsTimepoint: 2 years;To determine disease free survival (DFS) at 2 years and 5 yearsTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactShivakumar Gudi
Tata Memorial Hospital
Outcome results
None listed