Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Sponsor
Fudan University
Study ID
NCT04227886
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • Capecitabine-Irinotecan Combination — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2019
Status verified
Jan 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Good response
    TRG of 0-1 is defined as good response.
  • Arm: Poor response
    TRG of 2-3 is defined as poor response.
  • Arm: Light toxicity
    No grade 3-4 toxicities occur during neoadjuvant therapy.
  • Arm: Heavy toxicity
    Grade 3-4 toxicities occur during neoadjuvant therapy.

Primary Outcome Measure

TRG [ Time Frame: Surgery scheduled 6-8 weeks after the end of neoadjuvant therapy ]

Central Contacts

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