FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL)
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
2 other identifiers
interventional
738
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
ExpectedMay 22, 2026
May 1, 2026
8.2 years
October 1, 2015
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
3 years
Secondary Outcomes (6)
Curative resection rate
2 years
Overall survival (OS)
5 years
Relapse-free survival (RFS)
5 years
Down-staging of primary tumors
2 years
Toxicity assessed using the NCI common toxicity criteria, version 4.0.
2 years
- +1 more secondary outcomes
Study Arms (2)
Perioperative chemotherapy
EXPERIMENTALPerioperative chemotherapy with mFOLFOX6 or CAPOX regimens
Postoperative chemotherapy
ACTIVE COMPARATORPostoperative chemotherapy with mFOLFOX6 or CAPOX regimens
Interventions
mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) for 6 cycles followed by colectomy (3 to 5 weeks after) followed by mFOLFOX6 (6 cycles); CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) for 4 cycles followed by colectomy (3 to 5 weeks after) followed by CAPOX (4 cycles).
Colectomy (maximum 4 weeks after randomization) followed by mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) for 12 cycles; Colectomy (maximum 4 weeks after randomization) followed by CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) for 8 cycles
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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.
- Heart failure grade III/IV (NYHA-classification).
- Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Breast- feeding or pregnant women
- Lack of effective contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Related Publications (1)
Hu H, Zhang J, Li Y, Wang X, Wang Z, Wang H, Kang L, Liu P, Lan P, Wu X, Zhen Y, Pei H, Huang Z, Zhang H, Chen W, Zeng Y, Lai J, Wei H, Huang X, Chen J, Chen J, Tao K, Xu Q, Peng X, Liang J, Cai G, Ding K, Ding Z, Hu M, Zhang W, Tang B, Hong C, Cao J, Huang Z, Cao W, Li F, Wang X, Wang C, Huang Y, Zhao Y, Cai Y, Ling J, Xie X, Wu Z, Shi L, Ling L, Liu H, Wang J, Huang M, Deng Y; OPTICAL study group. Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial. J Clin Oncol. 2024 Sep 1;42(25):2978-2988. doi: 10.1200/JCO.23.01889. Epub 2024 Apr 2.
PMID: 38564700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanhong Deng, M.D.
Sixth Affiliated Hospital, Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 8, 2015
Study Start
January 1, 2015
Primary Completion
March 15, 2023
Study Completion (Estimated)
April 1, 2031
Last Updated
May 22, 2026
Record last verified: 2026-05