FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL) (OPTICAL)
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|ClinicalTrials.gov Identifier: NCT02572141|
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : May 16, 2019
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens Drug: Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||738 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2022|
Experimental: Perioperative chemotherapy
Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens
Drug: Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens
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).
Active Comparator: Postoperative chemotherapy
Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens
Drug: Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens
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
- Disease-free survival [ Time Frame: 3 years ]Defined as the time from randomization to relapse or death, whichever occurred first.
- Curative resection rate [ Time Frame: 2 years ]Curative resection defined as complete tumor resection with all margins being negative.
- Overall survival (OS) [ Time Frame: 5 years ]Defined as the time from randomization to death from any cause.
- Relapse-free survival (RFS) [ Time Frame: 5 years ]Defined as the time from randomization to relapse.
- Down-staging of primary tumors [ Time Frame: 2 years ]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. [ Time Frame: 2 years ]The grade of toxicity will be assessed using the NCI common toxicity criteria, version 4.0.
- Postoperative complications [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572141
|Contact: Yanhong Deng, M.D.||email@example.com|
|The Sixth Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Yanhong Deng, M.D. 008613925106525 firstname.lastname@example.org|
|Principal Investigator:||Yanhong Deng, M.D.||Sixth Affiliated Hospital, Sun Yat-sen University|