Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis

May 11, 2017 updated by: Zhu Ji
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Cancer Hospital, FuDan University

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

Sampling Method

Non-Probability Sample

Study Population

Stage T3 or T4 and/or N+ rectal adenocarcinoma cancer eligible for neoadjuvant chemoradiation

Description

Inclusion Criteria:

  1. history of primary rectal cancer with distance from anal verge being less than 12 cm;
  2. histologically confirmed adenocarcinoma;
  3. initial pathological stage of T3 or T4 and/or N+;
  4. no history of initial distant metastases;
  5. Karnofsky Performance Status score of ≥75
  6. ≥18 years;≤75 years
  7. sign the inform consent

Exclusion Criteria:

  1. pregnancy or breast-feeding women
  2. serious medical illness
  3. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TRG
Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Tumor regression grade
Surgery scheduled 6-8 weeks after the end of chemoradiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response
Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Surgery scheduled 6-8 weeks after the end of chemoradiation
Overall Survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 years
From date of randomization until the date of death from any cause, assessed up to 10 years
Disease-free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
Local Control rate
Time Frame: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve
From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 2 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Up to 2 years

Collaborators and Investigators

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

Sponsor

Zhu Ji

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Anticipated)

December 30, 2017

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-006

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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