To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer A phase II clinical trial
Determine safety and efficacy of simultaneous integrated boost in neoadjuvant short-course RT for rectal cancer
Design
This is a phase 2, randomized, parallel-group, controlled clinical trial on 66 patients.
The rand function of Excel software was used for randomization.
Settings and conduct
In this study CTV will be delineated, encompassing the GTV with appropriate margins. The mesorectum and regional lymph nodes will be included based on tumor location.All patients in this study will receive radiotherapy using IMRT technique.
Short-course RT will be administered in 5 fractions, delivering 5 Gy per day to the gross tumor and regional lymph nodes (25 Gy over 5 consecutive days). A Simultaneous Integrated Boost will be applied, delivering an additional 5 Gy in 5 fractions (1 Gy per fraction) to the GTV, without increasing the total number of treatment sessions.
Patients are treated in the Radio Oncology Department of Namazi Hospital, Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient with stage II and III rectal cancer and diagnosis confirmed by biopsy and tumor range is 15 cm from the anus and renal and liver and bone marrow with normal function,
Exclusion criteria: distant metastasis at presentation and past history of radiation or surgery in pelvis for rectal cancer and comorbidity and patient's dissatisfaction for participating in trial
Intervention groups
Intervention group: Patients undergo short-term radiation therapy for 5 fractions, with 6 Gy administered in each session instead of 5 Gy, with an additional Gy given to the tumor mass.
"Control group": Short-course radiation therapy: 5 fractions, 5 Gy given each day to the entire tumor and lymph nodes.
Main outcome variables
The incidence of adverse events؛
Pathological complete response ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250702066338N1
Registration date:2025-12-13, 1404/09/22
Registration timing:prospective
Last update:2025-12-13, 1404/09/22
Update count:0
Registration date
2025-12-13, 1404/09/22
Registrant information
Name
saide Honarmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3843 6798
Email address
saideh1994.7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2026-06-21, 1405/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer A phase II clinical trial
Public title
To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient with stage II and III rectal cancer
Diagnosis confirmed by biopsy and pathology assessment
Tumor range is 15 cm from anus
ECOG= 0-2
Renal and liver and bone marrow with normal function
Exclusion criteria:
Distant metastasis at presentation
Past history of radiation or surgery in pelvis for rectal cancer
The patient with comorbidity
Patient's dissatisfaction to participate in the trial
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly selected from the hospital admission department with odd numbers in the admission office as the control group and even numbers in the admission office as the intervention group. They were numbered based on a random number table and named control and intervention groups using lowercase English letters.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
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
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7184995495
Approval date
2025-06-23, 1404/04/02
Ethics committee reference number
IR.SUMS.MED.REC.1404.204
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 ratio
Timepoint
8 weeks after radiotherapy
Method of measurement
Biopsy and pathology assessment
Secondary outcomes
1
Description
Incidence of adverse events
Timepoint
Every week in radiotherapy course then every 3 months for 2 years
Method of measurement
History and physical examination
Intervention groups
1
Description
Intervention group: Short-course radiotherapy will be administered in 5 fractions, delivering 5 Gy per day to the gross tumor and regional lymph nodes (total dose: 25 Gy over 5 consecutive days). A Simultaneous Integrated Boost (SIB) will be applied, delivering an additional 5 Gy in 5 fractions (1 Gy per fraction) to the GTV, without increasing the total number of treatment sessions.
Category
Treatment - Other
2
Description
"Control group": Short-term radiation therapy: 5 fractions, 5 Gy given each day to the entire tumor and lymph nodes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mohammad mohamadianpanah
Street address
Namazi hospital, Molasadra St
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5000
Email
mohpanah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Shiraz Univercity Of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2710
Email
mohammadi219@gmail.com
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
Mohammad mohamadianpanah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Namazi hospital, Molasadra St
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5000
Email
mohpanah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad mohamadianpanah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Namazi hospital, Molasadra St
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5000
Email
mohpanah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad mohamadianpanah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Namazi hospital, Molasadra St
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5000
Email
mohpanah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available