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Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer

NCT03038217 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-02-03

No results posted yet for this study

Summary

In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.

Conditions

  • Rectal Cancer, Adenocarcinoma
  • Neoadjuvant Chemoradiation

Interventions

DRUG

Capecitabine +/- Oxaliplatin

Patients in ACT group will undergo postoperative adjuvant chemotherapy with single agent Capecitabine regimen or combined Capecitabine +Oxaliplatin regimen.

PROCEDURE

local resection

Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma

PROCEDURE

radical resection

Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma

OTHER

No adjuvant chemotherapy

Patients in Non-ACT group will not undergo postoperative adjuvant chemotherapy.

Sponsors & Collaborators

  • Geneplus-Beijing Co. Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2020-12-31
Completion
2021-12-31

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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 NCT03038217 on ClinicalTrials.gov