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

NCT03038217 | Unknown Phase 3 DMC

• 1 other identifier: PekingUMCH-Colorectal Surgery
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer, Adenocarcinoma; Neoadjuvant Chemoradiation

Keywords

rectal cancer; neoajuvant chemoradiation; circulating tumor DNA

Outcome Measures

Primary Outcomes (3)

• 5y DFS

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

  5 years

• 5y LR

  The 5-year local recurrence rate of the patients.

  5 years

• 5y OS

  The 5-year overall survival rate of the patients.

  5 years

Secondary Outcomes (3)

• Changes of ctDNA level after surgery

  1 month

• Changes of ctDNA level after adjuvant therapy

  6 months

• Changes of ctDNA level when disease recurs

  5 year

Study Arms (4)

ACT group

EXPERIMENTAL

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

Non-ACT group

EXPERIMENTAL

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

Other: No adjuvant chemotherapy

LR group

EXPERIMENTAL

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

Procedure: local resection

RR group

EXPERIMENTAL

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

Procedure: radical resection

Interventions

Capecitabine +/- Oxaliplatin DRUG

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

ACT group

local resection PROCEDURE

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

Also known as: LR

LR group

radical resection PROCEDURE

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

Also known as: RR

RR group

No adjuvant chemotherapy OTHER

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

Non-ACT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Geneplus-Beijing Co. Ltd.: collaborator

Related Publications (4)

• 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.

  PMID: 25654990 BACKGROUND

• 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.

  PMID: 2779946 BACKGROUND

• 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.

  PMID: 27384348 BACKGROUND

• 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.

  PMID: 27459628 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOX; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Jiaolin Zhou, MD

CONTACT

8613910136704; conniezhjl@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 31, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 3, 2017

Record last verified: 2017-02