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

Zhu Ji1 site in 1 country500 target enrollmentJuly 1, 2014

ConditionsLocally Advanced Rectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Locally Advanced Rectal Cancer
Sponsor: Zhu Ji
Enrollment: 500
Locations: 1
Primary Endpoint: TRG
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 1, 2014

End Date

June 30, 2020

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zhu Ji

Responsible Party

Sponsor Investigator

Principal Investigator

Zhu Ji

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•pregnancy or breast-feeding women
•serious medical illness
•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

Outcomes

Primary Outcomes

TRG

Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation

Tumor regression grade

Secondary Outcomes

Pathologic Complete Response(Surgery scheduled 6-8 weeks after the end of chemoradiation)
Local Control rate(From date of randomization until the date of first documented pelvic failure, assessed up to 10 years)
Disease-free Survival(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)
Overall Survival(From date of randomization until the date of death from any cause, assessed up to 10 years)
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0(Up to 2 years)