Clinically diagnosed and histopathologically proved adenocarcinoma of rectum.
Conditions
Interventions
Treatment schedule for arm A is 425 mg/m2 5-
FU and 20mg/m2 LV per day bolus dose will be delivered during the first 4 days in the first week and then restarted for 3 days in the fifth week of the radiation therapy .
Radiotherapy with conventio
to the primary tumor and to the clinically positive nodes at a dose of 2.0 Gy per day,
once per day with a total dose of 50 Gy in 25 fractions over 5 weeks to the primary tumor.,Treatment schedule for arm B is oral capecitabine 825 mg/m2 twice per day through the course of radiation the
once per day with a total dose of 50 Gy in 25 fractions over 5 weeks to the primary tumor.
Active Comparator Drug,Active Comparator Drug
Infusional 5-
FU/LV concurrent with external beam radiotherapy as neoadjuvant.,Oral capecitabine tablet concurrent with external beam radiotherapy as neoadjuvant.
Sponsors
Bangabandhu Sheikh Mujib Medical University
Researcher
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Clinically diagnosed and histopathologically proved adenocarcinoma of rectum. 2)Distal margin of the tumor located within 12 cm from the anal verge on colonofiberscopy. 3)All patients will be diagnosed as locally advanced carcinoma of rectum , clinical TNM staging, stage II (T3-4N0) or stage III (T1-4N1-2) by transrectal ultrasonography and computerized tomography (CT) scanning or magnetic resonance imaging (MRI). 4)Age 18-70 years. 5)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below. 6)Patients without synchronous distant metastases. 7)Adequate bone marrow reserve a. white blood cell count ≥4000/mm3 b. absolute neutrophil count ≥1500/mm3 c. platelet count ≥100,000/mm3 d. haemoglobin ≥10g/dL 8)Adequate renal function a. serum creatinine level ≤ 1.5 mg/dl b. creatinine clearance rate ≥ 50mg/min 9)Adequate liver function a. liver transaminase levels ≤ 3 times the upper normal limit b. serum bilirubin level ≤ 1.5mg/dL
Exclusion criteria
Exclusion criteria: 1)Those who are not willing. 2)Patients with distant metastases. 3)Patients with other tumor types than adenocarcinoma. 4)Age below 18 years and above 70 years. 5)Patients with history of prior chemotherapy or radiotherapy. 6)Initial surgery (excluding diagnostic biopsy) of the primary site. 7)Patients with double primaries. 8)Pregnant or lactating woman. 9)Patient dropped out or lost to follow up before completion of study. 10)Serious concomitant medical illness including severe heart disease, uncontrolled diabetes mellitus, hypertension or renal diseases 11)Patient with uncontrolled infection. 12)Poor performance status (ECOG score >2). 13)Prisoners. 14)Family history of rectal cancer when it was diagnosed as hereditary nonpolyposis colorectal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size At the 3rd, 6th and 9th month after receiving chemotherapy RECIST criteria,Renal Function Weekly during chemotherapy and radiotherapy Serum Creatinine,Hemoglobin percentage Weekly during chemotherapy and radiotherapy Complete Blood Count, Pain Weekly during chemotherapy and radiotherapy Wong-Baker FACES pain rating scale,Liver Function Weekly during chemotherapy and radiotherapy SGOT,Myelosuppression Weekly during chemotherapy and radiotherapy Total and Differential Count of WBC | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Bangladesh
Contacts
Public ContactRanjan Bhowmick
Bangabandhu Sheikh Mujib Medical University
Outcome results
None listed