Health Condition 1: null- Carcinoma Rectum
Conditions
Interventions
Intervention1: Interval chemotherapy: Patients will receive concurrent chemoradiation (5040cGy at a daily fractin of 180 cGy, 5 days a week)with capecitabine (825 mg/sqm) for 5-6 weeks. An MRI scan wi
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: â??Histopathologically confirmed adenocarcinoma of the lower and middle third rectum, with the lower edge of the tumor within 12 cm from the anal verge â??Age 18 to 70 years â??ECOG performance status 0-2 â??Locally advanced tumor defined as presence of any one of the following on high-resolution thin slice (3mm) MRI: - Involved or threatened CRM (tumor or node extends to - Any T3 tumor in the lower rectum (within 6 cm from anal verge), T3c or T3d in mid rectum (ie-tumor extending >5mm beyond the muscularis propria) - Resectable T4 - T3/T4 N1 or T1-T4 N2 - Extramural vascular invasion â??No evidence of established distant metastasis â??Adequate haematological, liver and renal function (WBC >3 x 109/L, neutrophils >1.5 x 109/l and platelets >100 x 109/L; serum creatinine 50ml/min; serum bilirubin â??Normal clinical cardiovascular assessment â??Willing and able to give informed consent and comply with treatment schedule
Exclusion criteria
Exclusion criteria: â??Disease outside the mesorectal envelope (internal iliac/ lateral pelvic lymph nodes) â??Previous radiotherapy to the pelvis â??Previously received chemotherapy for the currently diagnosed cancer â??Synchronous colorectal or other malignancies â??Active stable or unstable angina, NYHA class 2 congestive cardiac failure, myocardial infarction in the past 1 year, acute coronary syndrome even if controlled, arrhythmias â??Serious uncontrolled intercurrent illness including uncontrolled hypertension or poorly controlled diabetes mellitus â??Patients with a history of previous malignancy in the past 5 years, excepting basal or squamous cell skin cancer or cervical carcinoma-in-situ. â??Known HIV, HBV or HCV infection â??Pregnant or lactating women or premenopausal women not using adequate contraception â??Patients with any other condition or concurrent medical or psychiatric disease who, in the opinion of the investigator, is not eligible to enter the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) [defined as absence of any detectable residual tumor cells in the resected specimen]Timepoint: completion of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Complicance to treatmentTimepoint: at end of treatment;Frequency and severity of adverse events (AE) during chemotherapy [National Cancer Instituteâ??s common toxicity criteria] and chemoradiation [using Radiation Therapy Oncology Groupâ??s toxicity criteria]Timepoint: end of chemoradiation and end of chemotherapy;Microscopic R0 resection rate [defined as negative resection margins including circumferential margin (CRM)] -Circumferential margin (CRM) involvement [defined as tumor â?¤1mm from the inked circumferential margin] -Tumor downstaging [defined as reduction of at least one level in T or N stage between the baseline MRI and histological stage] -Tumor regression grade (TRG) Timepoint: completion of surgery;Surgical complications: intra-operative and 30-day postoperative [according to Dindo score]Timepoint: during surgery and till 30 days after surgery | — |
Countries
India
Contacts
Public ContactRamakrishnan A S
Cancer Institute (WIA)
Outcome results
None listed