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

Primary Purpose

Rectal Cancer, Adenocarcinoma, Neoadjuvant Chemoradiation

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Capecitabine +/- Oxaliplatin

local resection

radical resection

No adjuvant chemotherapy

About this trial

This is an interventional treatment trial for Rectal Cancer, Adenocarcinoma focused on measuring rectal cancer, neoajuvant chemoradiation, circulating tumor DNA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.).
Patient is pregnant or lactating.
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.
Patient is participating in any other clinical trials within 30 days prior to screening.
Patient has severe mental illness.
Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

ACT group

Non-ACT group

LR group

RR group

Arm Description

Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.

Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.

Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)

Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)

Outcomes

Primary Outcome Measures

5y DFS

The 5-year disease free survival rate of the patients.

5y LR

The 5-year local recurrence rate of the patients.

5y OS

The 5-year overall survival rate of the patients.

Secondary Outcome Measures

Changes of ctDNA level after surgery

Changes of patients' ctDNA level after undergoing surgical resection of the tumor.

Changes of ctDNA level after adjuvant therapy

Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).

Changes of ctDNA level when disease recurs

Changes of patients' ctDNA level after disease recurrence happens

Full Information

NCT ID

NCT03038217

First Posted

December 20, 2016

Last Updated

February 2, 2017

Sponsor

Peking Union Medical College Hospital

Collaborators

Geneplus-Beijing Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03038217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2017 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Geneplus-Beijing Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer, Adenocarcinoma, Neoadjuvant Chemoradiation

Keywords

rectal cancer, neoajuvant chemoradiation, circulating tumor DNA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ACT group

Arm Type

Experimental

Arm Description

Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.

Arm Title

Non-ACT group

Arm Type

Experimental

Arm Description

Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.

Arm Title

LR group

Arm Type

Experimental

Arm Description

Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)

Arm Title

RR group

Arm Type

Experimental

Arm Description

Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)

Intervention Type

Drug

Intervention Name(s)

Capecitabine +/- Oxaliplatin

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

local resection

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

radical resection

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

No adjuvant chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

5y DFS

Description

The 5-year disease free survival rate of the patients.

Time Frame

5 years

Title

5y LR

Description

The 5-year local recurrence rate of the patients.

Time Frame

5 years

Title

5y OS

Description

The 5-year overall survival rate of the patients.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Changes of ctDNA level after surgery

Description

Changes of patients' ctDNA level after undergoing surgical resection of the tumor.

Time Frame

1 month

Title

Changes of ctDNA level after adjuvant therapy

Description

Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).

Time Frame

6 months

Title

Changes of ctDNA level when disease recurs

Description

Changes of patients' ctDNA level after disease recurrence happens

Time Frame

5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18 to 75 years old. Patients with surgically resectable colorectal cancer, while without distal metastasis of the disease. Patients with ASA physical status scroe of I to III. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions. Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups. Exclusion Criteria: 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.). Patient is pregnant or lactating. 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. Patient is participating in any other clinical trials within 30 days prior to screening. Patient has severe mental illness. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiaolin Zhou, MD

Phone

8613910136704

conniezhjl@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25654990

Citation

Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.

Results Reference

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PubMed Identifier

2779946

Citation

Stroun M, Anker P, Maurice P, Lyautey J, Lederrey C, Beljanski M. Neoplastic characteristics of the DNA found in the plasma of cancer patients. Oncology. 1989;46(5):318-22. doi: 10.1159/000226740.

Results Reference

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PubMed Identifier

27384348

Citation

Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.

Results Reference

background

PubMed Identifier

27459628

Citation

Zhou J, Chang L, Guan Y, Yang L, Xia X, Cui L, Yi X, Lin G. Application of Circulating Tumor DNA as a Non-Invasive Tool for Monitoring the Progression of Colorectal Cancer. PLoS One. 2016 Jul 26;11(7):e0159708. doi: 10.1371/journal.pone.0159708. eCollection 2016.

Results Reference

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

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