ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03038217
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Geneplus-Beijing Co. Ltd.
Information provided by (Responsible Party):
Guole Lin, Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer, Adenocarcinoma Neoadjuvant Chemoradiation Drug: Capecitabine +/- Oxaliplatin Procedure: local resection Procedure: radical resection Other: No adjuvant chemotherapy Phase 3

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Investigation of the Value of ctDNA Analysis in the Diagnosis, Treatment, and Surveillance of Patients With Surgically Resectable Colorectal Cancer
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.
Drug: 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.
Other: 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)
Procedure: local resection
Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma
Other Name: LR

Experimental: RR group
Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)
Procedure: radical resection
Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma
Other Name: RR




Primary Outcome Measures :
  1. 5y DFS [ Time Frame: 5 years ]
    The 5-year disease free survival rate of the patients.

  2. 5y LR [ Time Frame: 5 years ]
    The 5-year local recurrence rate of the patients.

  3. 5y OS [ Time Frame: 5 years ]
    The 5-year overall survival rate of the patients.


Secondary Outcome Measures :
  1. Changes of ctDNA level after surgery [ Time Frame: 1 month ]
    Changes of patients' ctDNA level after undergoing surgical resection of the tumor.

  2. Changes of ctDNA level after adjuvant therapy [ Time Frame: 6 months ]
    Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).

  3. Changes of ctDNA level when disease recurs [ Time Frame: 5 year ]
    Changes of patients' ctDNA level after disease recurrence happens



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038217


Contacts
Contact: Jiaolin Zhou, MD 8613910136704 conniezhjl@yahoo.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Geneplus-Beijing Co. Ltd.

Publications:
Responsible Party: Guole Lin, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03038217     History of Changes
Other Study ID Numbers: PekingUMCH-Colorectal Surgery
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guole Lin, Peking Union Medical College Hospital:
rectal cancer
neoajuvant chemoradiation
circulating tumor DNA

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents