MedTrace Logo

Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer

NCT04405206 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2020-10-14

No results posted yet for this study

Summary

Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait strategy (W\&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by total neoadjuvant treatment. Meanwhile we will look into the role of ctDNA in the prediction of regrowth and metastasis in the wait and wait process.

Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor, mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR were recommended for 'watch \& wait' approach or local excision (LE). The OPR and sphincter preservation rate (SPR) at 2 years will be analyzed.

As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research enrolled 3 other colorectal center in Beijing.

Conditions

  • Rectum Cancer

Interventions

DRUG

Oxaliplatin

OXA 130mg/m2

DRUG

Capecitabine

Cape 1000mg/m2

RADIATION

intensity modulated radiotherapy

IMRT 50.4Gy/22f

PROCEDURE

DRE-Endoscopy-MRI-CEA

examination process in follow up

PROCEDURE

Nonoperative Management

Watch and Wait

PROCEDURE

Local excision

For ymriT1N0 and near-cCR patients，LE is optional.

PROCEDURE

Total Mesorectal Excision

Standard TME surgery openly or laporoscopically

BEHAVIORAL

Quality of Life Questionnaires

QLQ C30 and QLQ CR29

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04405206 on ClinicalTrials.gov