Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03038217|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : February 3, 2017
|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|
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- 5y DFS [ Time Frame: 5 years ]The 5-year disease free survival rate of the patients.
- 5y LR [ Time Frame: 5 years ]The 5-year local recurrence rate of the patients.
- 5y OS [ Time Frame: 5 years ]The 5-year overall survival rate of the patients.
- Changes of ctDNA level after surgery [ Time Frame: 1 month ]Changes of patients' ctDNA level after undergoing surgical resection of the tumor.
- Changes of ctDNA level after adjuvant therapy [ Time Frame: 6 months ]Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).
- Changes of ctDNA level when disease recurs [ Time Frame: 5 year ]Changes of patients' ctDNA level after disease recurrence happens
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
|Contact: Jiaolin Zhou, MDfirstname.lastname@example.org|