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

Rectal Cancer, Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03038217
• Other study ID #: PekingUMCH-Colorectal Surgery
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 20, 2016
• Last updated: February 2, 2017
• Start date: February 2017
• Est. completion date: December 2021

Study information

• Verified date: February 2017
• Source: Peking Union Medical College Hospital
• Contact: Jiaolin Zhou, MD
• Phone: 8613910136704
• Email: conniezhjl[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Neoplasms
• Neoadjuvant Chemoradiation
• Rectal Cancer, Adenocarcinoma
• Rectal Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Geneplus-Beijing Co. Ltd.

References & Publications (4)

Reinert T, Schøler 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, Ørntoft 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5y DFS	The 5-year disease free survival rate of the patients.	5 years
Primary	5y LR	The 5-year local recurrence rate of the patients.	5 years
Primary	5y OS	The 5-year overall survival rate of the patients.	5 years
Secondary	Changes of ctDNA level after surgery	Changes of patients' ctDNA level after undergoing surgical resection of the tumor.	1 month
Secondary	Changes of ctDNA level after adjuvant therapy	Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).	6 months
Secondary	Changes of ctDNA level when disease recurs	Changes of patients' ctDNA level after disease recurrence happens	5 year