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Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer

NCT03484221 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-14

No results posted yet for this study

Summary

To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.

Conditions

  • Rectal Neoplasms
  • Drug Therapy
  • Radiation

Interventions

DRUG

FOLFOXIRI

IRINOTECAN 150 mg/m\^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m\^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m\^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).

RADIATION

Short-Course Radiation Therapy(5Gy*5)

Patients received a short-course radiation therapy(5Gy\*5) after 4 cycles of FOLFOXIRI.

DRUG

XELOX

OXALIPLATIN 130 mg/m\^2 IV over 2-h, day 1 Capecitabine 1000 mg/m\^2 twice daily days 1-14 every 3 weeks for 4 cycles.

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Jingdong Zhang · China Medical University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-10-01
Completion
2022-04-01

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT03484221 on ClinicalTrials.gov