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Trial record 28 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

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
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date May 16, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Disease-free survival [ Time Frame: 3 years ]
Defined as the time from randomization to relapse or death, whichever occurred first.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02572141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • R0 resection rate [ Time Frame: 2 years ]
    R0 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • 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).
    Other Names:
    • Oxaliplatin
    • 5-Fluorouracil
    • Capecitabine
    • Leucovorin
  • 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
    Other Names:
    • Oxaliplatin
    • 5-Fluorouracil
    • Capecitabine
    • Leucovorin
Study Arms  ICMJE
  • Experimental: Perioperative chemotherapy
    Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens
    Intervention: Drug: Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens
  • Active Comparator: Postoperative chemotherapy
    Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens
    Intervention: Drug: Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2015)
738
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to provide written informed consent.
  2. Histological or cytological documentation of adenocarcinoma of the colon (≥ 15 cm from the anal verge).
  3. 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).
  4. Male or female subjects > 18 years < 70 of age.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. 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.
  7. Non complicated primary tumor (obstruction, perforation, bleeding).
  8. No previous any systemic anticancer therapy for colon cancer disease.
  9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

Exclusion Criteria:

  1. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
  2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
  3. Heart failure grade III/IV (NYHA-classification).
  4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
  5. Subjects with known allergy to the study drugs or to any of its excipients.
  6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
  7. Breast- feeding or pregnant women
  8. Lack of effective contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yanhong Deng, M.D. 008613925106525 13925106525@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02572141
Other Study ID Numbers  ICMJE GIHSYSU10
C01 ( Other Identifier: CSWOG )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanhong Deng, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanhong Deng, M.D. Sixth Affiliated Hospital, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP