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

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03149978
• Other study ID #: FDRT-006
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 11, 2017
• Start date: July 1, 2014
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2017
• Source: Fudan University
• Contact: Ji Zhu, MD
• Phone: +86-2164175590
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Ji

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRG	Tumor regression grade	Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary	Pathologic Complete Response		Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary	Local Control rate	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
Secondary	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
Secondary	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 10 years
Secondary	Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0	Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0	Up to 2 years