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

Phase 3

• Conditions: Rectal Cancer, Adenocarcinoma; Neoadjuvant Chemoradiation
• Interventions: Drug: Capecitabine +/- Oxaliplatin; Other: No adjuvant chemotherapy; Procedure: local resection; Procedure: radical resection

• Registration Number: NCT03038217
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-29
• Study First Posted: 2017-01-31
• Status Verified: 2017-02
• Study Start: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT group	Capecitabine +/- Oxaliplatin	Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.
Non-ACT group	No adjuvant chemotherapy	Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.
LR group	local resection	Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)
RR group	radical resection	Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)

Primary Outcome Measures

Name	Time	Method
5y LR	5 years	The 5-year local recurrence rate of the patients.
5y DFS	5 years	The 5-year disease free survival rate of the patients.
5y OS	5 years	The 5-year overall survival rate of the patients.

Secondary Outcome Measures

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