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Trial record 73 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

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ClinicalTrials.gov Identifier: NCT01308086
Recruitment Status : Unknown
Verified August 2017 by Hellenic Oncology Research Group.
Recruitment status was:  Active, not recruiting
First Posted : March 3, 2011
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group

Tracking Information
First Submitted Date  ICMJE March 1, 2011
First Posted Date  ICMJE March 3, 2011
Last Update Posted Date August 9, 2017
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
Relapse Free Survival [ Time Frame: 3-years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01308086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
  • Overall Survival [ Time Frame: 3-years ]
  • Safety Profil according to NCI-CTAE v 3.0 [ Time Frame: q2w ]
    Percentage (%) of treatments delays and interaptions in each arm Percentage (%) of dose received versus planned dose in each arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer
Official Title  ICMJE A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer
Brief Summary The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer.
Detailed Description

Six months of adjuvant chemotherapy with 5-FU and oxaliplatin for patients with stage III colon cancer is the world-wide standard of care, based on the MOSAIC and C-07 trials. However, it leads to significant cost, toxicity, and inconvenience. In particular, the onset of oxaliplatin induced cumulative dose-dependent neuropathies is a significant issue. The ability to maintain efficacy with a reduced duration of therapy would have clear advantage to patients, to providers, and to the health care system.

Multiple large trials in the 1990s demonstrated that the previous standard of 12 months of therapy could be reduced to 6 months. A single small trial with 5-FU alone demonstrated similar outcomes for 3 versus 6 months of therapy. Thus, it is proposed to definitively evaluate the non-inferiority of 3 months of oxaliplatin-based adjuvant chemotherapy versus the current standard of 6 months. The primary endpoint will be disease-free survival (DFS).

It is essential to have sufficient power to eliminate the possibility of clinically meaningful inferiority of 3 months of therapy: a huge number of patients will be necessary. Previous efforts and experience have conclusively demonstrated that in colon cancer, a single, global trial is impractical. Consequently, an international, prospective pooled analysis will be performed, gathering data of independent trials run in different countries, to answer the single primary hypothesis that 3 months of adjuvant therapy with FOLFOX/XELOX is non-inferior to the current standard of 6 months. Among six planned countries, the Greek intergroup will conduct one of these trials.

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 CRC
Intervention  ICMJE
  • Drug: 5-Fluorouracil
    5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 12 cycles
    Other Name: 5-FU
  • Drug: Leucovorin
    Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 12 cycles
  • Drug: Oxaliplatin
    Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles
    Other Name: LoHP
  • Drug: Capecitabine
    Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles
    Other Name: Xeloda
  • Drug: Oxaliplatin
    Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles
    Other Name: LoHP
  • Drug: 5-Fluorouracil
    5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 6 cycles
    Other Name: 5-FU
  • Drug: Leucovorin
    Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 6 cycles
  • Drug: Capecitabine
    Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles
    Other Name: Xeloda
  • Drug: Oxaliplatin
    Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles
    Other Name: LoHP
  • Drug: Oxaliplatin
    Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles
    Other Name: LoHP
Study Arms  ICMJE
  • Active Comparator: FOLFOX 4 - 6months or XELOX -6months
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Drug: Oxaliplatin
  • Experimental: FOLFOX4 -3months or XELOX -3months
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
    • Drug: Capecitabine
    • Drug: Oxaliplatin
    • Drug: Oxaliplatin
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: March 2, 2011)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically- - confirmed adenocarcinoma of the colon or rectum stage III or stage with at least one of the follow characteristics T4 tumours, undifferentiated tumor grade >3, bowel obstruction or perforation, vascular or lymphatic or perineural invasion, <12 nodes examined, Stage IV.
  • Signed written informed consent
  • Randomization between 2 -8 weeks after curative surgery
  • Age >18 years
  • ECOG performance Status 0-1
  • Pretreatment CEA within UNL
  • Post-menopausal women or women willing to accept the use of an effective contraception. Pre-menopausal women should have a negative pregnancy test within 72 hours prior to randomization
  • Men should also accept to use an effective contraception
  • R0 resections

Exclusion Criteria:

  • Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")
  • Evidence of other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
  • No pregnant or lactating women
  • Presence of clinically relevant cardiovascular disease
  • Presenc of medical history or current evidence of CNS disease
  • Presence of peripheral neuropathy ≤ grade 1 (CTCAE v. 3.0)
  • History of clinically relevant psychiatric disability, precluding informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01308086
Other Study ID Numbers  ICMJE CT/09.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hellenic Oncology Research Group
Study Sponsor  ICMJE Hellenic Oncology Research Group
Collaborators  ICMJE University Hospital of Crete
Investigators  ICMJE
Principal Investigator: John Souglakos, MD University Hospital of Crete, Dep of Medical Oncology
Study Chair: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
PRS Account Hellenic Oncology Research Group
Verification Date August 2017

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