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

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
carboplatin
paclitaxel
carboplatin
paclitaxel
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring quality of life, weekly therapy, neurotoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Oncologico Bari, Oncologia Medica
  • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
  • Ospedale Fatebenefratelli, U.O. di Oncologia
  • Azienda Ospedaliera G. Rummo
  • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
  • Azienda Ospedaliera C. Poma
  • Azienda Ospedaliera V. Cervello
  • Ospedale S. Massimo, Day Hospital Oncologico
  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
  • Ospedale S. Chiara
  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
  • Ospedale Mazzoni
  • Policlinico Universitario
  • Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
  • Ospedale Fatebenefratelli
  • Ospedale Senatore Antonio Perrino
  • Universita Cattolica del Sacro Cuore
  • Ospedale A. Manzoni
  • Istituto Nazionale Tumori
  • A.O. Univeristaria Policlinico
  • Azienda Ospedaliera D. Cotugno
  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
  • Università Federico II, Cattedra di Oncologia Medica
  • Ospedale Silvestrini
  • Ospedale Civile S. Spirito
  • A.O. S. Maria degli Angeli
  • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
  • A.O. di Udine S. Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

weekly chemotherapy

every 3 weeks chemotherapy

Outcomes

Primary Outcome Measures

quality of life
progression free survival

Secondary Outcome Measures

overall survival
response rate
toxicity
describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'

Full Information

First Posted
April 15, 2008
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00660842
Brief Title
Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Acronym
MITO-7
Official Title
Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2008 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
quality of life, weekly therapy, neurotoxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
weekly chemotherapy
Arm Title
B
Arm Type
Active Comparator
Arm Description
every 3 weeks chemotherapy
Intervention Type
Procedure
Intervention Name(s)
carboplatin
Intervention Description
AUC 6 IV day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
175 mg/m2 IV day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 2 IV every week
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
60mg/m2 IV every week
Primary Outcome Measure Information:
Title
quality of life
Time Frame
weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
Title
progression free survival
Time Frame
every 6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
24 months
Title
response rate
Time Frame
after 9 and 18 weeks of therapy
Title
toxicity
Time Frame
weekly during therapy
Title
describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
Time Frame
at study entry
Title
describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
Time Frame
at study entry
Title
describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'
Time Frame
at study entry

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marilina Piccirillo, M.D.,
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D.
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Oncologico Bari, Oncologia Medica
City
Bari
State/Province
BA
ZIP/Postal Code
70126
Country
Italy
Facility Name
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Azienda Ospedaliera G. Rummo
City
Benevento
State/Province
BN
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
City
Campobasso
State/Province
CB
ZIP/Postal Code
86100
Country
Italy
Facility Name
Azienda Ospedaliera C. Poma
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Azienda Ospedaliera V. Cervello
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Ospedale S. Massimo, Day Hospital Oncologico
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
State/Province
TN
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Facility Name
Ospedale Mazzoni
City
Ascoli Piceno
Country
Italy
Facility Name
Policlinico Universitario
City
Bari
Country
Italy
Facility Name
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
City
Bari
Country
Italy
Facility Name
Ospedale Fatebenefratelli
City
Benevento
Country
Italy
Facility Name
Ospedale Senatore Antonio Perrino
City
Brindisi
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Campobasso
Country
Italy
Facility Name
Ospedale A. Manzoni
City
Lecco
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Milano
Country
Italy
Facility Name
A.O. Univeristaria Policlinico
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera D. Cotugno
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università Federico II, Cattedra di Oncologia Medica
City
Napoli
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
Country
Italy
Facility Name
Ospedale Civile S. Spirito
City
Pescara
Country
Italy
Facility Name
A.O. S. Maria degli Angeli
City
Pordenone
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
City
Roma
Country
Italy
Facility Name
A.O. di Udine S. Maria della Misericordia
City
Udine
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24582486
Citation
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.
Results Reference
result

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Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

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