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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03149978

Enrollment

500

Registered

2017-05-11

Start date

2014-07-01

Completion date

2020-06-30

Last updated

2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiation, treatment effect prediction, metabonomics

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactJi Zhu, MD

leo.zhu@126.com+86-2164175590

Outcome results