A study on neoadjuvant chemoradiotherapy with capecitabine in locally advanced rectal cancer.
- Conditions
- Clinically diagnosed and histopathologically proved adenocarcinoma of rectum.
- Registration Number
- TCTR20180516003
- Lead Sponsor
- Bangabandhu Sheikh Mujib Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 140
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/d
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method /A N/A N/A