Comparison of Xelox Chemotherapy with Folfox in Patients with Non-Metastatic Colon Cancer
Design
Clinical trial with control group, with parallel, non-blinding, randomized, phase 2 groups on 48 patients. Excel software rand function was used for randomization.
Settings and conduct
Forty-eight patients with stage II colorectal cancer are randomly assigned to two groups using randomized block after enrollment. The studied diets are Xelox and Folfox. The study site is the blood clinic of Qazvin province hospital. Metastases are examined.
Participants/Inclusion and exclusion criteria
48 patients in stage II colorectal cancer
Inclusion criteria:
- Age 18 years
- One or two of the following tests performed up to 30 days before the start of the study:
• Platelets ≥ 100000
White blood cells WBC ≥ 3000 - Hemoglobin ≥ 10
Total bilirubin ≤ 1.5 times the maximum normal
• Serum creatinine ≤ 1.5 times the maximum normal level
Exclusion criteria:
- Pregnancy, breastfeeding
- According to the treating physician (due to safety or inability of the patient to cooperate) causes the patient to be unable to participate in the study
- Inability to swallow
Intervention groups
Group A: XELOX includes a 2-hour intravascular injection. Oxaliplatin injection of 130 mg / m2 on day 1 plus oral capsaicin 1000 mg / m2 twice daily on days 15-1 of the 3-week cycle on an outpatient basis. The first dose of capsaicin is given on the evening of day 1 and the last dose on the morning of day 15 (28 doses per cycle).
Group B: FOLFOX includes weekly injections of 5FU 500 mg / m2, Leucovorin 500 mg / m2 for 6 weeks and oxaliplatin 85 mg / m2 in weeks 1, 3, 5, repeated for 3 periods.
Main outcome variables
Comparison of local recurrence and distant metastasis of patients in the two groups after treatment and evaluation of patient survival in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210913052454N1
Registration date:2022-04-28, 1401/02/08
Registration timing:registered_while_recruiting
Last update:2022-04-28, 1401/02/08
Update count:0
Registration date
2022-04-28, 1401/02/08
Registrant information
Name
Alireza Esmaeilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
dr.nafas.rastgoo.20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Xelox with Folfox Chemotherapy in Patients with Non-Metastatic Colon Cancer
Public title
Comparison of Xelox with Folfox Chemotherapy in Patients with Non-Metastatic Colon Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Platelet ≥ 100000
White blood cell WBC ≥ 3000 - hemoglobin ≥ 10
Serum creatinine ≤ 1.5 times the maximum normal level
Exclusion criteria:
Pregnancy, breastfeeding
Inability to swallow
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups a and b using the balance block randomization method. The size of each block is 4. The method of balanced randomization allocation for participants in a randomized clinical trial study is the effect of Xelox (group a) and Folfox (group b) chemotherapy on reducing local recurrence and distant metastasis of non-metastatic colon cancer patients.
The tool is random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Intervention group:Xelox diet group.Includes a 2-hour intravascular injection. Oxaliplatin injection of 130 mg / m2 on day 1 plus oral capsaicin 1000 mg / m2 twice daily on days 15-1 of the 3-week cycle on an outpatient basis. The first dose of capsaicin is given in the evening of day 1 and the last dose in the morning on day 15 (28 doses per cycle).
Category
Treatment - Drugs
2
Description
Control group:Folfox diet group.Includes weekly injections of 5 FU 500 mg / m2, Leucovorin 500 mg / m2 for 6 weeks and oxaliplatin 85 mg / m2 at weeks 1, 3, 5, repeated for 3 periods.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after individuals are unidentified
When the data will become available and for how long
After published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any analysis of the submitted data is allowed. A message should be sent to the author's email in order to access the data or documents.
From where data/document is obtainable
Refer to the email of Dr. Alireza Esmailzadeh
What processes are involved for a request to access data/document
After the publication of the article, the applicant is able to access the information by sending an email to the author and its duration is about one month.