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

January 4, 2016 updated by: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative concurrent chemoradiation
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.
Radiation: preoperative concurrent chemoradiation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gene expression in different response groups
Time Frame: 6 months after radical surgery
6 months after radical surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival, disease free survival and local-regional free survival
Time Frame: 3 years after pre-operative chemoradiotherapy
3 years after pre-operative chemoradiotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicity
Time Frame: during concurrent chemoradiation
any G3/4 toxicities according to CTC 3.0
during concurrent chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Jing Jin, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0905001040531

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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