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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

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.


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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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).
Other Names:
  • Oxaliplatin
  • 5-Fluorouracil
  • Capecitabine
  • Leucovorin

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
Other Names:
  • Oxaliplatin
  • 5-Fluorouracil
  • Capecitabine
  • Leucovorin




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]
    Defined as the time from randomization to relapse or death, whichever occurred first.


Secondary Outcome Measures :
  1. Curative resection rate [ Time Frame: 2 years ]
    Curative resection defined as complete tumor resection with all margins being negative.

  2. Overall survival (OS) [ Time Frame: 5 years ]
    Defined as the time from randomization to death from any cause.

  3. Relapse-free survival (RFS) [ Time Frame: 5 years ]
    Defined as the time from randomization to relapse.

  4. 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).

  5. 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.

  6. Postoperative complications [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yanhong Deng, M.D. 008613925106525 13925106525@163.com

Locations
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China, Guangdong
The Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yanhong Deng, M.D.    008613925106525    13925106525@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yanhong Deng, M.D. Sixth Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Yanhong Deng, Associate professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02572141     History of Changes
Other Study ID Numbers: GIHSYSU10
C01 ( Other Identifier: CSWOG )
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs