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Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer

NCT04227886 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2020-01-14

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasm Malignant Carcinoma
  • Chemoradiotherapy
  • Neoadjuvant Therapy
  • Predictive Biomarkers
  • Adenocarcinoma

Interventions

RADIATION

Radiation

Neoadjuvant radiotherapy consisted of 50 Gy in 25 fractions using intensity-modulated radiotherapy to the primary tumor and to mesorectal, presacral, and internal iliac lymph nodes.

DRUG

Capecitabine-Irinotecan Combination

The concurrent chemotherapy consists of capecitabine 625 mg/m2 twice daily 5 days per week and combined with weekly irinotecan. The irinotecan dose was used based on UGT1A1 genotype of 80mg/m2 for UGT1A1\*1\*1 or 65mg/m2 for UGT1A1\*1\*28 weekly, followed by a cycle of XELIRI.

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • Harbin Medical University

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Ji Zhu, MD · Fudan University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227886 on ClinicalTrials.gov