Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Consolidation arm: Long course chemoradiotherapy followed by consolidation chemotherapy followed by surgery
Control Intervention1: Induct
Sponsors
Dr B Borooah Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed stage II and III adenocarcinoma of the rectum without radiological or clinical evidence of distant metastasis. 2.MRI evidence of Extramural vascular invasion and, or involved meso rectal fascia, and, or Metastatic lateral lymph nodes. 3.Tumor located within 15 cm from the anal verge. 4.Age between 18 years to 70 years. 5.Performance status of 0 to 2. 6.No history of any other systemic treatment or radiotherapy for rectal cancer or pelvic malignancy. 7.No history of underlying medical disease which might interfere with systemic therapy. 8.Adequate organ function â?? Normal bone marrow function Hemoglobin more than 8 gram per deci litre, total leucocyte count more than 3000 per cubic millimeter, absolute neutrophil count more than 1500 per cubic millimeter, platelet count more than 100,000 per cubic millimeter), normal renal function (normal serum creatinine and calculated creatinine clearance more than 60ml per min), normal liver function tests(Total Bilirubin not more than 2 milligram per decilitre, transaminases less than 5 times upper limit of normal, serum albumin more than 3 gram per decilitre)
Exclusion criteria
Exclusion criteria: 1.Any Histology other than Adeno Carcinoma 2.Upfront Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles 3.Age less than 18 Years, greater than 70 Years 4.Performance status more than ECOG 2 5.Tumor involving lumbosacral nerve roots on MRI 6.Concurrent uncontrolled medical condition; uncontrolled Diabetes Mellitus, Renal dysfunction, Cardiac function, decompensated liver disease, known psychiatric illness 7.Pregnancy or breast feeding 8.Previous history of pelvic irradiation 9.Inability to give informed consent 10.Distant metastasis. 11.Recurrent rectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Pathological Complete Response between the two groupsTimepoint: 1st, 2nd, 3rd, 4rth year | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the 2-year DFS of the two groupsTimepoint: 2 year | — |
Countries
India
Contacts
Public ContactDr Jyotiman Nath
Dr. B. Borooah Cancer Institute.
Outcome results
None listed