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Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

Primary Purpose

Stage IV Rectal Cancer, Liver Metastasis, Resectable

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

About this trial

This is an interventional treatment trial for Stage IV Rectal Cancer, Liver Metastasis, Resectable

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

  • Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis

Sites / Locations

  • Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical ScienceRecruiting
  • Cancer Hospital, CAMSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Short course radiotherapy

Arm Description

Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks. After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Outcomes

Primary Outcome Measures

percentage of patients undergo R0 surgery during the follow-up

Secondary Outcome Measures

The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)

Full Information

First Posted
July 12, 2015
Last Updated
July 27, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02510378
Brief Title
Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Official Title
Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (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
Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.
Detailed Description
Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks. After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Rectal Cancer, Liver Metastasis, Resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short course radiotherapy
Arm Type
Experimental
Arm Description
Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks. After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
Short course radiotherapy
Intervention Description
Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks. After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.
Primary Outcome Measure Information:
Title
percentage of patients undergo R0 surgery during the follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)
Time Frame
3 months

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: Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings. Exclusion Criteria: Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Ren
Phone
8610-87788122
Email
renhua2009@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, chairman
Phone
8610-87788122
Email
jingjin1025@163.com
Facility Information:
Facility Name
Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing jin
Phone
8610-87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name & Degree
hua ren
Phone
8610-87788122
Email
renhua2009@hotmail.com
First Name & Middle Initial & Last Name & Degree
jing jin, professor
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

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Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

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