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

Primary Purpose

Colon Cancer

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens

Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

Exclusion Criteria:

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.

Sites / Locations

The Sixth Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perioperative chemotherapy

Postoperative chemotherapy

Arm Description

Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens

Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens

Outcomes

Primary Outcome Measures

Disease-free survival

Defined as the time from randomization to relapse or death, whichever occurred first.

Secondary Outcome Measures

Curative resection rate

Curative resection defined as complete tumor resection with all margins being negative.

Overall survival (OS)

Defined as the time from randomization to death from any cause.

Relapse-free survival (RFS)

Defined as the time from randomization to relapse.

Down-staging of primary tumors

Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (7th version).

Toxicity assessed using the NCI common toxicity criteria, version 4.0.

The grade of toxicity will be assessed using the NCI common toxicity criteria, version 4.0.

Postoperative complications

Full Information

NCT ID

NCT02572141

First Posted

October 1, 2015

Last Updated

June 15, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02572141

Brief Title

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

Acronym

OPTICAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

OVERVIEW OF TRIAL DESIGN: This trial is a a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with locally advanced (T4 or T3 with extramural depth≧5 mm) colon cancer patients will be randomly assigned, in a 1:1 ratio, to receive either perioperative or postoperative chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

738 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Perioperative chemotherapy

Arm Type

Experimental

Arm Description

Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens

Arm Title

Postoperative chemotherapy

Arm Type

Active Comparator

Arm Description

Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens

Intervention Type

Drug

Intervention Name(s)

Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens

Other Intervention Name(s)

Oxaliplatin, 5-Fluorouracil, Capecitabine, Leucovorin

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens

Other Intervention Name(s)

Oxaliplatin, 5-Fluorouracil, Capecitabine, Leucovorin

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-free survival

Description

Defined as the time from randomization to relapse or death, whichever occurred first.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Curative resection rate

Description

Curative resection defined as complete tumor resection with all margins being negative.

Time Frame

2 years

Title

Overall survival (OS)

Description

Defined as the time from randomization to death from any cause.

Time Frame

5 years

Title

Relapse-free survival (RFS)

Description

Defined as the time from randomization to relapse.

Time Frame

5 years

Title

Down-staging of primary tumors

Description

Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (7th version).

Time Frame

2 years

Title

Toxicity assessed using the NCI common toxicity criteria, version 4.0.

Description

The grade of toxicity will be assessed using the NCI common toxicity criteria, version 4.0.

Time Frame

2 years

Title

Postoperative complications

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanhong Deng, M.D.

Organizational Affiliation

Sixth Affiliated Hospital, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sixth Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

12. IPD Sharing Statement

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

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