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Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer (MITO-7)

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ClinicalTrials.gov Identifier: NCT00660842
Recruitment Status : Active, not recruiting
First Posted : April 17, 2008
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 17, 2008
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE November 2008
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2010)
  • quality of life [ Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy ]
  • progression free survival [ Time Frame: every 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
quality of life [ Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2010)
  • overall survival [ Time Frame: 24 months ]
  • response rate [ Time Frame: after 9 and 18 weeks of therapy ]
  • toxicity [ Time Frame: weekly during therapy ]
  • describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: at study entry ]
  • describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) [ Time Frame: at study entry ]
  • describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' [ Time Frame: at study entry ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
  • progression free survival
  • overall survival
  • response rate [ Time Frame: after 9 and 18 weeks of therapy ]
  • toxicity [ Time Frame: weekly during therapy ]
  • describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: at study entry ]
  • describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) [ Time Frame: at study entry ]
  • describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' [ Time Frame: at study entry ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Official Title  ICMJE Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
Brief Summary The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.
Detailed Description The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
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 Ovarian Cancer
Intervention  ICMJE
  • Procedure: carboplatin
    AUC 6 IV day 1 every 21 days
  • Drug: paclitaxel
    175 mg/m2 IV day 1 every 21 days
  • Drug: carboplatin
    AUC 2 IV every week
  • Drug: paclitaxel
    60mg/m2 IV every week
Study Arms  ICMJE
  • Experimental: A
    weekly chemotherapy
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
  • Active Comparator: B
    every 3 weeks chemotherapy
    Interventions:
    • Procedure: carboplatin
    • Drug: paclitaxel
Publications * Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28.

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2010)
800
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2008)
400
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
  • Indication for chemotherapy
  • Age > 18 years
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
  • Performance Status (ECOG) > or = 3.
  • Previous chemotherapy
  • Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
  • Neutrophils < 2000 x mm3, platelets < 100000 x mm3
  • Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values)
  • Present or suspected hemorrhagic syndromes
  • Inability to comply with protocol and follow-up
  • Inability to access study site for clinical visits
  • Refusal of informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00660842
Other Study ID Numbers  ICMJE MITO-7
2008-001754-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute, Naples
Study Sponsor  ICMJE National Cancer Institute, Naples
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandro Pignata, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Marilina Piccirillo, M.D., National Cancer Institute, Naples
Principal Investigator: Ciro Gallo, M.D., Ph.D. University of Campania "Luigi Vanvitelli"
PRS Account National Cancer Institute, Naples
Verification Date March 2021

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