Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Kasturba Medical College Manipal
Eligibility
Inclusion criteria
Inclusion criteria: Biopsy confirmed adenocarcinoma. Tumour location 0-10 cm from the anal verge-Low and mid Patient requiring neoadjuvant therapy- radiation alone, chemoradiation or TNT MRI defined cT1-4 N0-2 M0. Performance status 0-2.
Exclusion criteria
Exclusion criteria: Presence of distant metastases. Prior history of radiotherapy or surgery to the pelvis. Synchronous malignancies requiring treatment. Severe comorbidities precluding any curative disease-directed therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the three-year organ preservation rates achieved using the standard neoadjuvant approaches in locally advanced rectal cancer.Timepoint: Three year rate | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the feasibility and tolerability of delivering a brachytherapy boost in patients desiring organ preservation for low rectal cancer.Timepoint: Two years;To measure and compare the gross tumour volumes during radiotherapy planning based on various imaging modalities.Timepoint: Three years;To determine the dosimetry, internal target volume, set up errors and nodal response rates of patients with extra-mesorectal nodes treated with nodal boost, along with quality of life QOL and acute toxicity.Timepoint: three years;To assess the toxicity and QOL of patients achieving complete response and on wait-and-watch protocol.Timepoint: Three years;To measure the local control, disease-free survival and overall survival and compare the outcome of those with and without organ preservation.Timepoint: 5 years;To explore patients and oncologists perspectives on organ preservation in low rectal cancer.Timepoint: One year | — |
Countries
India
Contacts
Public ContactDr Shirley Lewis Salins
Kasturba Medical college
Outcome results
None listed