NCT03038217

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer, Adenocarcinoma
• Neoadjuvant Chemoradiation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2017-01-31
• Last updated: 2017-02-03