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Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

NCT03071198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-03-07

No results posted yet for this study

Summary

Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer

Conditions

  • Rectum Cancer

Interventions

PROCEDURE

TME

1. Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus. 2. At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations.

RADIATION

Concurrent chemo-radiotherapy

Three-dimensional conformal radiotherapy as following: CTV 44Gy/22 times＋GTV1 6Gy/3 times(2Gy/time/day，5 days a week，totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day

DRUG

neoadjuvant CT

CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks

DRUG

adjuvant CT

CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • binbin cui · Harbin Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-09-30
Completion
2021-09-30

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 NCT03071198 on ClinicalTrials.gov