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

NCT03149978 | Unknown DMC

• 1 other identifier: FDRT-006
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiation; treatment effect prediction; metabonomics

Outcome Measures

Primary Outcomes (1)

• TRG

  Tumor regression grade

  Surgery scheduled 6-8 weeks after the end of chemoradiation

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage T3 or T4 and/or N+ rectal adenocarcinoma cancer eligible for neoadjuvant chemoradiation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhu Ji: lead

Study Sites (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Jia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2.

  PMID: 30041962 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma，serum and urine

Central Study Contacts

Ji Zhu, MD

CONTACT

+86-2164175590; leo.zhu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: July 1, 2014
• Primary Completion: December 30, 2017
• Study Completion: June 30, 2020
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

CN (1)