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

February 2, 2017 updated by: Guole Lin, Peking Union Medical College Hospital

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

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.

Study Overview

Detailed Description

A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis.

Research objects: patients with surgically resectable colorectal cancer. After giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, (post-NCRT for NCRT patients), postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The 3 year disease free survival (3y-DFS) will be the primary end-point.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 18 to 75 years old.
  2. Patients with surgically resectable colorectal cancer, while without distal metastasis of the disease.
  3. Patients with ASA physical status scroe of I to III.
  4. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
  5. Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.

Exclusion Criteria:

  1. Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
  2. Patient is pregnant or lactating.
  3. Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
  4. Patient is participating in any other clinical trials within 30 days prior to screening.
  5. Patient has severe mental illness.
  6. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT group
Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.
Patients in ACT group will undergo postoperative adjuvant chemotherapy with single agent Capecitabine regimen or combined Capecitabine +Oxaliplatin regimen.
Experimental: Non-ACT group
Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.
Patients in Non-ACT group will not undergo postoperative adjuvant chemotherapy.
Experimental: LR group
Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)
Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma
Other Names:
  • LR
Experimental: RR group
Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)
Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma
Other Names:
  • RR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5y DFS
Time Frame: 5 years
The 5-year disease free survival rate of the patients.
5 years
5y LR
Time Frame: 5 years
The 5-year local recurrence rate of the patients.
5 years
5y OS
Time Frame: 5 years
The 5-year overall survival rate of the patients.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of ctDNA level after surgery
Time Frame: 1 month
Changes of patients' ctDNA level after undergoing surgical resection of the tumor.
1 month
Changes of ctDNA level after adjuvant therapy
Time Frame: 6 months
Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).
6 months
Changes of ctDNA level when disease recurs
Time Frame: 5 year
Changes of patients' ctDNA level after disease recurrence happens
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 29, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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