Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer

  • STATUS
    Recruiting
  • participants needed
    250
  • sponsor
    Fudan University
Updated on 26 January 2022
cancer
metastasis
chemoradiotherapy
capecitabine
irinotecan
primary tumor
chemotherapy regimen
rectal cancer
rectal carcinoma
cancer treatment
adenocarcinoma

Summary

Backgrounds: A multicenter randomized phase III trial (NCT02605265) proved that adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response. The treatment toxicities were increased but tolerable.

Purposes: This study aims to identify the predictive biomarkers (from patients' tumor biopsy samples and peripheral blood samples before neoadjuvant therapy) for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy.

Description

OBJECTIVES
Primary
  • Establish a predictive model for response based on tissue RNA and plasma exosome RNA
  • Establish a predictive model for toxicities based on tissue RNA and plasma exosome RNA
Secondary
  • Internal validation of the established predictive models
  • External validation of the established predictive models
OUTLINE

-Treatment: Patients receive neoadjuvant therapy and surgery per the protocol. Samples collection Tumor tissue and peripheral blood will be collected prior to neoadjuvant therapy.

-Grouping: Response: Patients will be dichotomized into two groups based on the TRG. TRG of 0-1 is defined as good response. TRG of 2-3 is defined as poor response.

Toxicities: Patients will be dichotomized into two groups based on the grade of AEs. No grade 3-4 toxicities occurs during neoadjuvant therapy is defined as light toxicities. Grade 3-4 toxicities occur during neoadjuvant therapy is defined as heavy toxicities.

-Predictive Model Construction: Using RNA sequencing method to obtain the whole genome transcription profiles of the tumor tissue and plasm exosome RNA. Compare the gene expression differences between the two response groups and the two toxicity groups. Predictive models of response and toxicities are constructed.

-Internal Validation: Patients treated at Fudan University Shanghai Cancer Center (N=50) per the protocol will be enrolled as the internal validation cohort. Samples of tissue and plasm will be collected and analyzed. The performance of the model will be evaluated by the correlation of the predicted response/toxicities and the actual response/toxicities.

-External Validation: Patients treated at Liao'ning Cancer Hospital & Institute (N=50) and Harbin Medical University Cancer Hospital (N=50) per the protocol will be enrolled as two external validation cohorts. Samples of tissue and plasm will be collected and analyzed. The performance of the model will be evaluated by the correlation of the predicted response/toxicities and the actual response/toxicities.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Neoadjuvant Therapy, Chemotherapy, Chemotherapy, Rectal Cancer, Rectal Cancer, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Vulvar Dysplasia and Carcinoma, Chemoradiation, Chemoradiotherapy, Advanced Malignancies, Predictive Biomarkers, Malignant Adenoma, Rectal Neoplasm Malignant Carcinoma, induction therapy, neoadjuvant treatment, adenocarcinomas, rectal carcinoma
Treatment Radiation, Capecitabine-Irinotecan Combination
Clinical Study IdentifierNCT04227886
SponsorFudan University
Last Modified on26 January 2022

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