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Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Primary Purpose

Rectal Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
preoperative concurrent chemoradiation
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 Neoplasms focused on measuring rectal carcinoma, preoperative concurrent chemoradiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0).
  • Distance from the lower bound of tumor to the anal verge is less than 12 cm.
  • KPS score not less than 70
  • Can be tolerated chemotherapy and radiotherapy.
  • No history of radiation therapy to the pelvis.
  • Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
  • Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. -

Exclusion Criteria:

  • Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
  • Pregnant or lactating patients.
  • Fertility but did not use contraceptive measures.
  • Existing active infection.
  • Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
  • Concurrent treatment with other anticancer drugs.
  • Can not complete treatment or follow-up

Sites / Locations

  • Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preoperative concurrent chemoradiation

Arm Description

Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.

Outcomes

Primary Outcome Measures

gene expression in different response groups

Secondary Outcome Measures

overall survival, disease free survival and local-regional free survival

Full Information

First Posted
August 14, 2013
Last Updated
January 4, 2016
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01930942
Brief Title
Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
Official Title
Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (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
The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
Detailed Description
For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
rectal carcinoma, preoperative concurrent chemoradiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
preoperative concurrent chemoradiation
Arm Type
Experimental
Arm Description
Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
Intervention Type
Radiation
Intervention Name(s)
preoperative concurrent chemoradiation
Intervention Description
Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
Primary Outcome Measure Information:
Title
gene expression in different response groups
Time Frame
6 months after radical surgery
Secondary Outcome Measure Information:
Title
overall survival, disease free survival and local-regional free survival
Time Frame
3 years after pre-operative chemoradiotherapy
Other Pre-specified Outcome Measures:
Title
toxicity
Description
any G3/4 toxicities according to CTC 3.0
Time Frame
during 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: Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0). Distance from the lower bound of tumor to the anal verge is less than 12 cm. KPS score not less than 70 Can be tolerated chemotherapy and radiotherapy. No history of radiation therapy to the pelvis. Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. - Exclusion Criteria: Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). Pregnant or lactating patients. Fertility but did not use contraceptive measures. Existing active infection. Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. Concurrent treatment with other anticancer drugs. Can not complete treatment or follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, MD
Phone
+86-13601365130
Email
jingjin1025@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Jin, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Jin, MD
Phone
+8613601365130
Email
jingjin1025@163.com

12. IPD Sharing Statement

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Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

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