Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Febin Antony
Eligibility
Inclusion criteria
Inclusion criteria: those with ECOG Performance Status 0 to 2, histologically confirmed rectal adenocarcinoma below the peritoneal reflection as per MRI, cT4 or cN2, or MRF involvement, or EMVI.
Exclusion criteria
Exclusion criteria: those with, metastatic disease (M1), prior malignancies within the last 5 years (excluding non-melanoma skin cancer), contraindications to chemotherapy or radiotherapy, bowel obstruction for whom emergency diversion is required, uncontrolled systemic illness or cardiac dysfunction, deemed unfit for TNT by the treating team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR): Defined as no residual tumor in the surgical specimen (ypT0N0) based on tumor regression score.Timepoint: at 3, 6, 9, 12, 15, 18, 21, 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Toxicity: Measured using CTCAE v5.0 for grade 3-4 toxicities during and after treatment.Timepoint: at 3, 6, 9, 12, 15, 18, 21, 24 months.;Disease-Free Survival (DFS): Time from diagnosis to locoregional or distant relapse, or death from rectal carcinoma.Timepoint: at 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 months.;Locoregional Failure (LRF): Relapse of the tumor in the pelvic region.Timepoint: at 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 months.;Overall Survival (OS): Time from diagnosis to death caused by colorectal cancer or treatment-related mortality.Timepoint: at 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 months. | — |
Countries
India
Contacts
Public ContactFebin Antony
Amala Institute of Medical Sciences
Outcome results
None listed