Efficacy and Complications of Short Course versus Long Course Concurrent Chemo-radiotherapy followed by Consolidation Chemotherapy and Delayed Surgery among Patients with Rectal Cancer.
Neoadjuvant radio-chemotherapy is a standard approach for patients with locally advanced rectal adenocarcinoma. We want to compare the complications, treatment tolerance and efficacy of short course concurrent chemoradiotherapy with the standard long-course regimen. In this double arm interventional non-blinded study patients with rectal adenocarcinoma located at 5 to 15 centimeters from anal verge without previous pelvic radiotherapy and chemotherapy will be enrolled. Individuals intolerant for chemotherapy, with existent other concomitant malignancy and distant metastasis will be excluded. Our estimated sample size is 72 people with attrition and lost to follow up taken account. The randomization is made by permuted blocks. The participant will undergo either short course radiotherapy consisted of 25 gray in 5 fractions in 5 days (one week) or long course radiotheray consisted of 50 gray in 25 fractions (5 weeks) both with concurrent chemotherapy. Three to four weeks after completion of radiotherapy, participants receive one cycle of consolidation chemotherapy and then undergo total mesorectal excision surgery at least 8 weeks after last session of radiotherapy. The patients will be followed regularly for complications due to radiotherapy and chemotherapy before and after surgery to 30 days (for perioperative morbidity and mortality). Our primary outcome will be complications and treatment tolerance of these approaches compared together and secondary outcome would be pathologic response to neoadjuvant treatment, overall survival and local control.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110424266N3
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Reza Ghalehtaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2520
Email address
r-ghaletaki@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-15, 1397/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Complications of Short Course versus Long Course Concurrent Chemo-radiotherapy followed by Consolidation Chemotherapy and Delayed Surgery among Patients with Rectal Cancer.
Public title
Short-Course Versus Long-Course Chemo-Radiotherapy in Cancer of Large Bowel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Rectal Adenocarcinoma Confirmed by Pathology; Both Genders; Ages 18 to 80; Clinical Stages T3-4 or Lymph node Positive by MRI or Endosonography; Tumor Location 5 to 15 cm above anal verge; Good Performance Status (Eastern Cooperative Oncology Group 0-1).
Exclusion Criteria: Concurrent Malignancy other than Rectal Cancer; No tolerance for Chemotherapy; Previous Pelvic Radiotherapy; Distant Metastasis; Impaired Renal Function.
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Tehran University of Medical Sciences
Street address
Poursina Street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2017-09-16, 1396/06/25
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3475
Health conditions studied
1
Description of health condition studied
Rectal Adenocarcinoma
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Complications
Timepoint
At the Initiation of Radiotherapy up to one month after surgery
Method of measurement
Common terminology criteria for cancer related therapy adverse events
Secondary outcomes
1
Description
Postop Tumor Stage
Timepoint
After Surgery
Method of measurement
Pathology Report
Intervention groups
1
Description
َ1st Arm: Short course radiotherapy with 25 Gy in 5 fractions with concurrent chemotherapy regimen including Capecitabine 625mg/m2/bid for 5 days and Oxaliplatin 50mg/m2/day for 1 day then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session.
Category
Treatment - Drugs
2
Description
2nd Arm (Control): Long course radiotherapy with 50 Gy in 25 fractions with concurrent Capecitabine 825mg/m2/bid for 5 days each week then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute
Full name of responsible person
Mahdi Aghili
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
No 206, First Floor, Official Building, Medical Faculty, Poursina Street, 16th Azar Street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Radiation Oncology, Tehran University of Medical Sciences
Full name of responsible person
Mahdi Aghili
Position
Head of Department of Radiation Oncology
Other areas of specialty/work
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2520
Fax
Email
aghili@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Radiation Oncology, Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Resident
Other areas of specialty/work
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6119 2520
Fax
Email
Rezaght@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Radiation Oncology, Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Resident
Other areas of specialty/work
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6119 2520
Fax
Email
rezaght@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)