Purpose: The aim of this study is to evaluate the efficacy and safety of low-dose rate endorectal brachytherapy in patients with clinical stage II-III resectable low rectal cancer. This study assumes that the addition of low-dose endorectal brachytherapy 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 three fractions of 5 Gy endorectal brachytherapy, 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). 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:IRCT201501059979N2
Registration date:2015-02-21, 1393/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-21, 1393/12/02
Registrant information
Name
Mohammad Mohammadianpanah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5168
Email address
mohpanah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Radiation Oncology, Colorectal Research Center, Namazi Hospital, Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-05-06, 1394/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy and safety of low-dose rate endorectal brachytherapy in patients with clinical stage T2N1 or T3-4N0-2 resectable low rectal cancer
Public title
Study of brachytherapy in rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
• Pathologically proved adenocarcinoma of the rectum
• Age 18 or older
• Clinically staged II-III tumor by MRI and/or EUS
• ECOG performance status of 0 or 1
• Tumors located at up to10 cm of the anus
• 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 tumors >12 cm from the anal verge.
• Near obstructing or bulky tumors which will not allow application of the endorectal applicator before or after chemoradiation
• 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 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 University of Medical Sciences
Street address
Medical Research Ethics Committee of Shiraz University of Medical Sciences
City
Shiraz
Postal code
71913613511
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
CT-P-9356-5686
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C20, C21.1
ICD-10 code description
Rectal and anal canal neoplasms
Primary outcomes
1
Description
pathological complete response
Timepoint
Before intervention and After surgical resection
Method of measurement
Pathologic examination
2
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)
Secondary outcomes
empty
Intervention groups
1
Description
All patients will receive three fractions of 5 Gy endorectal brachytherapy, each spaced apart by 4 days (+/- 1 day) and during 2 weeks. Subsequently, 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). 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