Clinical evaluation and comparison of rectal toxicity and absorbed dose effects of radiation therapy with and without rectal retractor on patients with prostate cancer
Rectal toxicity and absorptive dose effects of radiation therapy with and without rectal retractor on patients with prostate cancer will be compared and clinically evaluated
Design
A non blinded clinical trial with two parallel groups of 36 patients
Settings and conduct
In this clinical trial prostate cancer patients who are referred to Firuzgar hospital and their cancer is pathologically approved and have not undergone prostate surgery are included. Patients (36 patients) are randomly assigned in to intervention group and control group (each group consists of 18 patients). Patients in intervention group are treated with rectal retractor and patients in control group are treated without rectal retractor. Lower gastrointestinal complications will be assessed during treatment and 1-3 months later and 9-12 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: pathologically confirmed prostate cancer and patients who are 40 years old or older
Exclusion criteria include: anorectal disorders (Hemorrhoids, rectal fistula)
Intervention groups
Intervention group: patients who are treated with rectal retractor
Control group: patients who are treated without rectal retractor
Intervention:A previously designed rectal retractor by Mahdavi et.al which was designed by CATIA V5R2 software and is made of Acrylic that is equivocal to body texture. The device is used in 20 sessions of 35 sessions of radiation therapy.
Main outcome variables
early and late lower gastrointestinal complications grade based on RTOG criteria, Rectum to prostate distance in CT scan images,
Dose volume histograms for rectum and planning treatment volume (PTV),
Dosimetrics parameters including: maximum dose (Dmax) ,minimum dose (Dmin), mean dose (Dmean), the dose which covers 30% of rectum volume (D30%), the dose that covers 50% of rectum volume (D50%)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180919041070N4
Registration date:2020-04-21, 1399/02/02
Registration timing:retrospective
Last update:2020-04-21, 1399/02/02
Update count:0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Pedram Fadavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8584
Email address
fadavi.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
2019-12-21, 1398/09/30
Actual recruitment end date
2020-02-23, 1398/12/04
Trial completion date
2020-05-18, 1399/02/29
Scientific title
Clinical evaluation and comparison of rectal toxicity and absorbed dose effects of radiation therapy with and without rectal retractor on patients with prostate cancer
Public title
Rectal retractor in prostate cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with localized prostate cancer who are candidates for radiation therapy with 5 fields technique
pathologically confirmed prostate cancer in patients who have not undergone prostate surgery
Block randomization is used to randomize subjects. The block size is Four (Two patients in the intervention group and Two patient in the control group). For random allocation, since 36 patients should be allocated in two groups of 18, nine random blocks (each block consisting of four patients) are generated using an online software (WWW.sealedenvelope.com).
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
Research Ethics Committee of Medical School of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411188001
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
early and late lower gastrointestinal complications grade based on Radiation therapy oncology group (RTOG) criteria
Timepoint
During treatment course, 1-3 months after treatment, 9-12 months after treatment
Method of measurement
according to Radiation therapy oncology group (RTOG) criteria
2
Description
Rectum to prostate distance in CT scan images
Timepoint
At the beginning of study (During intervention)
Method of measurement
Axial CT scan images
Secondary outcomes
1
Description
Maximum dose (Dmax)
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
2
Description
Minimum dose (Dmin)
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
3
Description
Mean dose (Dmean)
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
4
Description
Dose 30% (D30%): The dose that covers 30% of rectum
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
5
Description
Dose 50% (D50%): The dose that covers 50% of rectum
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
6
Description
Dose volume histograms for rectum and planning treatment volume (PTV)
Timepoint
at the intervention time
Method of measurement
Radiation therapy treatment planning system (Varian Eclipse v.13.6 )
Intervention groups
1
Description
Intervention group: Patients who are treated with rectal retractor in order to retract the rectum and distance it from prostate, Intervention: A rectal retractor probe which is designed with CATIA V5R2 software and is constructed by Mahdavi et. al. in Iran University of Medical Sciences. The probe is made of Acrylic which is equivalent to body tissue.The rectal retractor is used in the intervention group for 20 sessions of 35sessions of radiation therapy treatment sessions.
Category
Rehabilitation
2
Description
Control group: Patients with localized prostate cancer who are treated with 35 sessions radiation therapy without rectal retractor