A study on neoadjuvant chemoradiotherapy with capecitabine in locally advanced rectal cancer.

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20180516003
• Date of registration: 16/05/2018
• Prospective Registration: No
• Primary sponsor: Bangabandhu Sheikh Mujib Medical University
• Public title: A study on neoadjuvant chemoradiotherapy with capecitabine in locally advanced rectal cancer.
• Scientific title: Oral capecitabine is a good alternative choice of infusional 5-FU as a neoadjuvant chemotherapeutic agent in chemoradiotherapy for the treatment of locally advanced rectal cancer.
• Date of first enrolment: 01/01/2017
• Recruitment status: Active, not recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20180516003
• Study type: Interventional
• Study design: Non-randomized
• Phase: N/A

Countries of recruitment

Bangladesh

Contacts

• Name: Ranjan Kumar Bhowmick
• Affiliation: Bangabandhu Sheikh Mujib Medical University

• Name: Ranjan Kumar Bhowmick
• Affiliation: Bangabandhu Sheikh Mujib Medical University

Key inclusion & exclusion 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: 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Clinically diagnosed and histopathologically proved adenocarcinoma of rectum.

Intervention(s)

Infusional 5-FU/LV concurrent with external beam radiotherapy as neoadjuvant.,Oral capecitabine tablet concurrent with external beam radiotherapy as neoadjuvant.

Active Comparator Drug,Active Comparator Drug

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 conventional fraction, to the primary tumor and to the clinically positive nodes at a dose of 2.0 Gy per day, 5 days per week, 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 therapy five days a week beginning the day of the start of radiation therapy and ending the evening of the last dose of radiation therapy.
Radiotherapy with conventional fraction, to the primary tumor and to the clinically positive nodes at a dose of 2.0 Gy per day, 5 days per week, once per day with a total dose of 50 Gy in 25 fractions over 5 weeks to the primary tumor.

Primary Outcome(s)

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(s)

N/A N/A N/A

Source(s) of Monetary Support

Bangabandhu Sheikh Mujib Medical University

Secondary Sponsor(s)

Researcher

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Institutional Review Board

Results

• Date Completed: 31/12/2017