Study of efficacy and safety of neoadjuvant chemotherapy with CAPOX regimen and neoadjuvant chemoradiation in complete pathologic responce in locally advanced rectal cancer
Purpose: The aim of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy in patients with clinical stage II-III resectable low rectal cancer. This study assumes that the addition of neoadjuvant chemotherapy to conventional neoadjuvant chemoradiation enhances the pathological response compared to historical controls treated with conventional neoadjuvant chemoradiation alone. Study design: This is a pilot single arm phase II clinical trial. Methods: Preliminary evaluations included comprehensive history and physical examination, colonoscopy, serum carcinoembryonic antigen (CEA) level, abdominal and pelvic ultrasonography and computed tomography (CT) scans and/or pelvic MRI and/or transrectal ultrasonography. Eligible patients must to have newly diagnosed locally advanced low rectal cancer, no prior therapy, ECOG performance status of 0 or 1, and normal organ function. Patients with prior history of chemotherapy or radiation therapy to the pelvis were excluded. Intervention: All patients will receive one course of chemotherapy with CAPOX regimen consisted of infusional Oxaliplatin 130 mg/m2 first day and oral capecitabine, 2000 mg/m2 twice daily during first to 14th days, after 3 weeks followed by chemoradiation (45 Gy) included conventional external beam radiotherapy using megavoltage linear accelerator photons. Concurrent chemotherapy consisted of oral capecitabine, 825 mg/m2 twice daily during the whole period of the radiotherapy with weekend breaks (Tuesdays and Fridays). Then will receive 2 course of chemotherapy with CAPOX regimen with 3 weeks interwall. All patients will undergo standard surgery 6 weeks after completion of chemoradiation. Pathologic response will be defined through pathologic examination. Treatment-related complications will be determined according to the Common Terminology Criteria for Adverse Events (version 4.0). The endpoints of this study include pathological complete response rate and adverse events
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129403N2
Registration date:2016-09-24, 1395/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Mohammad Mohammadian Panah
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 9361 3511
Email address
mirzaies@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy and safety of neoadjuvant chemotherapy with CAPOX regimen and neoadjuvant chemoradiation in complete pathologic responce in locally advanced rectal cancer
Public title
Effect of preoperative chemotherapy in the treatment of patients with locally advanced rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pathologically proved adenocarcinoma of the rectum; age 18 years old or older; clinically staged II-III tumor by MRI and/or EUS; ECOG performance status of 0 or 1; no previous history of malignancy, pelvic radiotherapy or chemotherapy; normal or adequate bone marrow reserve; normal or adequate liver and kidney function. Exclusion criteria: patients with distant metastatic disease; prior history of radiation therapy to the pelvis; prior history of chemotherapy for rectal cancer; active connective tissue disease such as scleroderma or Crohn's disease; uncontrolled diabetes mellitus, hypertension or recent cardiovascular disease; significant neuropathy; any previous or recent hypersensitivity or contraindication for chemotherapy agents.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz school of Medical Sciences
Street address
Medical Research Ethics Committee of Shiraz scool of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SUMS.MED.REC.1395.23
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
pathological complete response
Timepoint
Before intervention and After surgical resection
Method of measurement
Pathologic examination
Secondary outcomes
1
Description
Treatment-related side effects
Timepoint
Weekly measurement from the first week to the end of intervention
Method of measurement
According to the Common Terminology Criteria for Adverse Events (version 4.0)
Intervention groups
1
Description
All patients will receive one course of chemotherapy with CAPOX regimen consisted of infusional Oxaliplatin 130 mg/m2 first day and oral capecitabine, 2000 mg/m2 twice daily during first to 14th days. after 3 weeks this treatment will be followed by chemoradiation included conventional external beam radiotherapy using megavoltage linear accelerator photons. A total dose of 45 Gy external beam radiotherapy will be delivered via a daily fraction of 1.8 Gy, with five fractions per week. Concurrent chemotherapy consisted of oral capecitabine, 825 mg/m2 twice daily during the whole period of the radiotherapy with weekend breaks (Tuesdays and Fridays). Then will receive 2 course of chemotherapy with CAPOX regimen with 3 weeks interwall. All patients will undergo standard surgery 6 weeks after completion of chemoradiation. Pathologic response will be defined through pathologic examination. Treatment-related complications will be determined according to the Common Terminology Criteria for Adverse Events (version 4.0). The endpoints of this study include pathological complete response rate and adverse events (gastrointestinal toxicity).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Radiation Oncology
Full name of responsible person
Mohammad Mohammadianpanah
Street address
Department of Radiation Oncology, Namazi Hospital,
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Sayed Basir Hashemi
Street address
Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences