NCT02572141Active, not recruitingPhase 3

FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL)

A Phase III Study to Evaluate the 3-year Disease-free Survival in Patients With Locally Advanced Colon Cancer Receiving Either Perioperative or Postoperative Chemotherapy With FOLFOX or CAPOX Regimens

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

BACKGROUND: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography is a robust method for measuring the depth of tumor invasion and identifying the CC patients with poor prognosis, who may benefit from perioperative chemotherapy. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOX or CAPOX regimens compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, locally advanced, but resectable colon cancer. OBJECTIVE: The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOX or CAPOX regimens compared to postoperative chemotherapy in patients with locally advanced colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.

Status (registry): Active, not recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 738 (estimated)
First submitted: 1 Oct 2015
Start date: 1 Jan 2015
Primary completion date: 15 Mar 2023
Lead sponsor: Sun Yat-sen University
Diseases: Colorectal cancer
NCT number: NCT02572141

What you commit to

Study type: Interventional · Phase 3
Planned participants: 738
From 1 Jan 2015 to the primary completion date, 15 Mar 2023
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.

Other illness

Heart failure grade III/IV (NYHA-classification).
Subjects with known allergy to the study drugs or to any of its excipients.

Other

Breast- feeding or pregnant women
Lack of effective contraception.

Who the study is looking for

Willing and able to provide written informed consent.
Histological or cytological documentation of adenocarcinoma of the colon (≥ 15 cm from the anal verge).
Determined preoperatively by either spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with more than 5 mm protrusion into adjacent mesenteric fat) or T4 (tumor penetrates to the surface of the visceral peritoneum or directly invades or is adherent to adjacent organs or structures).
Male or female subjects \> 18 years \< 70 of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
CT or MRI scans (done within 30 days of registration) of the chest, abdomen and pelvis all without clear evidence of distant metastatic (M1) disease.
Non complicated primary tumor (obstruction, perforation, bleeding).
No previous any systemic anticancer therapy for colon cancer disease.
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status	Guangzhou	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.