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Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer

NCT01952951 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-09-13

No results posted yet for this study

Summary

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

Conditions

  • Rectal Neoplasms
  • Adenocarcinoma

Interventions

DRUG

Capecitabine Oxaliplatin

after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.

RADIATION

pelvic radiation capecitabine 5-fluorouracil

50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Sun Young Kim, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-09-30
Completion
2019-12-31

Countries

  • South Korea

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 NCT01952951 on ClinicalTrials.gov