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Ovarian CancerPhase 3MITO-7NCT00660842

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

A Phase 3 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 28 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
28 sitesItaly
Study dates
Nov 2008to Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Italy28 sites

  • Ospedale Mazzoni

    Ascoli Piceno

  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

    Aviano, PN, 33081

  • IRCCS Oncologico Bari, Oncologia Medica

    Bari, BA, 70126

  • Policlinico Universitario

    Bari

  • Universita di Bari Policinico I Clinical Ostetrica e Ginecologica

    Bari

  • Ospedale Fatebenefratelli, U.O. di Oncologia

    Benevento, BN, 82100

  • Azienda Ospedaliera G. Rummo

    Benevento, BN

  • Ospedale Fatebenefratelli

    Benevento

  • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia

    Bergamo, BG, 24128

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

    Campobasso, CB, 86100

  • Universita Cattolica del Sacro Cuore

    Campobasso

  • Ospedale A. Manzoni

    Lecco

  • Azienda Ospedaliera C. Poma

    Mantua, MN, 46100

  • Istituto Nazionale Tumori

    Milan

  • A.O. Univeristaria Policlinico

    Modena

  • Azienda Ospedaliera D. Cotugno

    Naples, 80131

  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

    Naples, 80131

  • Università Federico II, Cattedra di Oncologia Medica

    Naples

  • Azienda Ospedaliera V. Cervello

    Palermo, PA

  • Ospedale S. Massimo, Day Hospital Oncologico

    Penne, PE, 65017

  • Ospedale Silvestrini

    Perugia

  • Ospedale Civile S. Spirito

    Pescara

  • A.O. S. Maria degli Angeli

    Pordenone

  • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia

    Roma

  • Ospedale S. Chiara

    Trento, TN, 38100

  • A.O. di Udine S. Maria della Misericordia

    Udine

  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

    Vicenza, VI, 36100

Other trials in Italy

About this study

Official title: Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
carboplatin, paclitaxel
Keywords
quality of life, weekly therapy, neurotoxicity
Medical subject headings
Ovarian Neoplasms, Neurotoxicity Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00660842
Study groupRoleWhat they receive
AExperimentalweekly chemotherapy
Receives: Drug: carboplatin; Drug: paclitaxel
BActive comparatorevery 3 weeks chemotherapy
Receives: Procedure: carboplatin; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quality of life

    Measured: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy

  2. progression free survival

    Measured: every 6 months

Secondary outcomes (6)

  1. overall survival

    Measured: 24 months

  2. response rate

    Measured: after 9 and 18 weeks of therapy

  3. toxicity

    Measured: weekly during therapy

  4. describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis

    Measured: at study entry

  5. describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)

    Measured: at study entry

  6. describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'

    Measured: at study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00660842
Sponsor's protocol ID
MITO-7
Other IDs
2008-001754-40, 2008
Acronym
MITO-7
Status last verified
Mar 2023
First submitted
15 Apr 2008
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No

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.

    PubMed 24582486

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 28 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00660842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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MITO-7 Clinical Trial NCT00660842 | AzTrials