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Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer

NCT07090031 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-07-29

No results posted yet for this study

Summary

5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer.

Conditions

  • EFS
  • pCR Rate

Interventions

DRUG

TAS-102 in combination with oxaliplatin

Induction : TAS102 35mg/m2, twice a day for 5 days, on 1st, 3rd, 5th week; Oxliplatin 85mg/m2 on 1st and 2nd week; Rectal radiotherapy 50GY/25f in 5 weeks. 2 weeks no treatment. Consolidation: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 3 cycles. 4 weeks no treatment. Surgery Adjuvant chemotherapy: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 16 cycles.

Sponsors & Collaborators

  • Qingdao Central Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-12-01
Completion
2028-05-01

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 NCT07090031 on ClinicalTrials.gov