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TNT to Increase the Clinical Complete Response Rate for Distal LARC

NCT03840239 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-10-25

No results posted yet for this study

Summary

This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.

Conditions

  • Rectal Cancer
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III
  • Chemoradiation

Interventions

DRUG

Capecitabine, Oxaliplatin

Drug: Capecitabine, Oxaliplatin

RADIATION

External beam radiotherapy

External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume

PROCEDURE

Surgery

'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries

OTHER

Watch and wait strategy

Watch and wait strategy recommendation and discussion for cCR patients

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • WeiWei Xiao · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-12-25
Primary Completion
2023-12-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03840239 on ClinicalTrials.gov