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

Zhu Ji500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Locally Advanced Rectal Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

TRG

Tumor regression grade

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

Secondary Outcomes

Pathologic Complete Response

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

Local Control rate

Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve

Time frame: From date of randomization until the date of first documented pelvic failure, 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

Overall Survival

Time frame: 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

Time frame: Up to 2 years

Central Contacts

Ji Zhu, MD

CONTACT

+86-2164175590 leo.zhu@126.com

Data from ClinicalTrials.gov

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