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Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
conventional fraction
SIB
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
  • the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

Exclusion Criteria:

  • metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status > 3
  • patients not deemed fit for radiotherapy, capecitabine or surgery
  • pregnant or lactating patients
  • women with child bearing potential who lack effective contraception
  • patients below 18 years old

Sites / Locations

  • Cancer Hospital, CAMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional fraction

SIB

Arm Description

Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily

Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily

Outcomes

Primary Outcome Measures

• Pathological complete remission rate (pCR)

Secondary Outcome Measures

Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Full Information

First Posted
July 11, 2014
Last Updated
February 2, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02195141
Brief Title
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Official Title
Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional fraction
Arm Type
Active Comparator
Arm Description
Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
Arm Title
SIB
Arm Type
Experimental
Arm Description
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
Intervention Type
Radiation
Intervention Name(s)
conventional fraction
Intervention Description
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
Intervention Type
Radiation
Intervention Name(s)
SIB
Intervention Description
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
Primary Outcome Measure Information:
Title
• Pathological complete remission rate (pCR)
Time Frame
after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Description
Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time Frame
during preoperative treatment and after surgery for 5 years
Other Pre-specified Outcome Measures:
Title
• Disease-free survival
Description
Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.
Time Frame
3 year afte concurrent chemoradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound Exclusion Criteria: metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status > 3 patients not deemed fit for radiotherapy, capecitabine or surgery pregnant or lactating patients women with child bearing potential who lack effective contraception patients below 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, Professor
Phone
87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Ren, Attending
Phone
87788122
Email
renhua2009@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Jin, proffessor
Organizational Affiliation
Dept of Radiation oncology, Cancer hospital, CAMS
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital, CAMS
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Jin, professor
Phone
87788200
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name & Degree
Hua Ren, attending
Phone
87788122
Email
renhua2009@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

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