The investigation of the efficacy and safety of preoperative short-course radiation therapy and chemotherapy followed by delayed surgery in patients with rectal cancer
To determine the efficacy and safety of preoperative short-course radiation therapy and chemotherapy followed by delayed surgery in patients with rectal cancer
Design
This study is a phase II single arm clinical trial. The sample size was determined equals 50 subjects. The eligible subjects will be consecutively selected among the patients with rectal cancer.
Settings and conduct
This study will be conducted on patients with rectal cancer referred to radiation oncology department of Namazi hospital in Shiraz in 2019. All patients will be done 3 cycles of chemotherapy (with CAPOX regimen), short course RT and surgery. For RT, a dose of 25 Gy in 5 fractions over 1 week will be prescribed. Adverse effects of RT will be scored. A standard surgical planning (low anterior resection or abdomino-perineal resection) will be considered for all patients. Postsurgical pathology examination provides a macroscopic description of the specimen.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with newly diagnosed rectal cancer with up to 16 cm distance from anal verge
2. Histologically confirmed adenocarcinoma;
3. Initial pathological stage of T3 or T4 and/or N+;
4. No history of initial distant metastases;
5. ECOG-performance status < 2
6. Age ≥ 18 years
7. Adequate bone marrow, hepatic and renal functions
8. Signing the informed consent
Exclusion criteria:
1. Pregnancy
2. Previous pelvic radiotherapy
3. Hypersensitivity to fluorouracil, oxaliplatin or capecitabine
3. Serious medical illness
4. Distance metastasis
Intervention groups
In this clinical trial, only one intervention group was designed in which patients with rectal cancer will receive a cycle of chemotherapy (with CAPOX regimen) followed by short course RT followed by 2 weeks’ rest followed by 2 cycles of chemotherapy followed by surgery.
Main outcome variables
Pathologic complete response; Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190119042415N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
AliAkbar Hafezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4320
Email address
hafezi_a@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the efficacy and safety of preoperative short-course radiation therapy and chemotherapy followed by delayed surgery in patients with rectal cancer
Public title
Preoperative short-course radiation therapy in rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with newly diagnosed rectal cancer with up to 16 cm distance from anal verge
Histologically confirmed adenocarcinoma
Initial pathological stage of T3 or T4 and/or N+
No history of initial distant metastases
ECOG-performance status < 2 6. Age ≥ 18 years
Adequate bone marrow, hepatic and renal functions
Signing the informed consent
Exclusion criteria:
Pregnancy
Previous pelvic radiotherapy
Hypersensitivity to fluorouracil, oxaliplatin or capecitabine
Serious medical illness
Distance metastasis
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
IR.sums.med.rec.1397.437
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
Pathologic complete response
Timepoint
Post operation
Method of measurement
Pathologic examination
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly during intervention course
Method of measurement
Radiation therapy oncology group toxicity criteria
Intervention groups
1
Description
Intervention group: The patients with rectal cancer will receive a cycle of chemotherapy (with CAPOX regimen) followed by short course RT followed by 2 weeks’ rest followed by 2 cycles of chemotherapy followed by surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mohammad Mohammadianpanah
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mohpanah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Deputy of Research, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Hafezi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
ّForty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
hafezi_a@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mohammadianpanah
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mohpanah@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Hafezi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
ّForty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
hafezi_a@sums.ac.ir
Sharing plan
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
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research centers
Under which criteria data/document could be used
In order to improve the treatment of the disease and subsequent research and with the permission of the authors
From where data/document is obtainable
Department of radiation oncology of Shiraz university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors