Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: ARM A: Short course Radiotherapy with concurrent CAPOX followed by Total Neoadjuvant Therapy consisting of 3 cycles of NACT with CAPOX followed by Surgery.
Comparator -ARM B: Short co
Sponsors
Dr Jagadish Sing
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1.Age: 18 to 65 years 2.Sex: Any 3.Diagnosis: Histologically proven adenocarcinoma of rectum 4.Stage: Locally advanced disease Node positive OR Radiological CRM adequate (more than equal 2 mm) for upfront surgery 5.Performance Status: ECOG 0 to 2 6.Adequate Hematological and Biochemical Parameters: Hemoglobin more than 10 gm per dL ANC more than 1500 per cmm Platelets more than 100,000 per cmm Creatinine clearance more than 50 mL per min per1.73 m Total bilirubin less than double of Upper normal limit. SGOT/SGPT less than 2.5 times of Upper normal limit. Albumin more than 3.5 g per dL 7. Cardiac Fitness: Cleared for platinum and 5 FU based chemotherapy 8. Consent: Willing to provide informed consent for screening and trial participation
Exclusion criteria
Exclusion criteria: 1. Not competent to give Informed Consent 2. Known to be allergic or hypersensitive to Platinum compounds, or 5FU derivatives 3. Any absolute contraindications to Radiotherapy and or Chemotherapy 4. Any uncontrolled co morbid conditions despite treatment like DM, Hypertension, which in the opinion of the investigator can compromise safety of the subject. 5. Metastatic disease 6. Willing to Provide Informed Consent for screening and inclusion in the Trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Response at Surgery Following TNT (Total Neoadjuvant Therapy)Timepoint: Arm A : At baseline, at 3 months. ( for Delayed surgery) Arm B : At baseline , at 3 weeks. ( for immediate surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Jagadish Sing
Outcome results
None listed