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

• Conditions: Locally Advanced Rectal Cancer

• Registration Number: NCT03149978
• Lead Sponsor: Zhu Ji

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2017-12-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TRG	Surgery scheduled 6-8 weeks after the end of chemoradiation	Tumor regression grade

Secondary Outcome Measures

Name	Time	Method
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	Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve
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	Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China