NCT00657878|UnknownPhase 3

Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

MITO-8

Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.

National Cancer Institute, Naples ClinicalTrials.gov

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2 other identifiers

MITO-82008-001755-22

Study Type

interventional

Target

215

Locations

3 countries

Sites

Timeline

RegisteredApr 2008

StartedNov 2008

CompletionDec 2023

Brief Summary

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

215

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline

Completed

Started Nov 2008

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach

3 countries

40 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.1 years study duration

First Submitted

Initial submission to the registry

April 8, 2008

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed

7 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed

15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

November 13, 2023

Status Verified

March 1, 2023

Enrollment Period

15.1 years

First QC Date

April 8, 2008

Last Update Submit

November 9, 2023

Conditions

Ovarian Cancer

Keywords

platinum free intervalchemotherapy

Outcome Measures

Primary Outcomes (1)

overall survival
18 months

Secondary Outcomes (4)

progression free survival
18 months
changes in quality of life
9 months
number of objective responses
6 months
worst grade toxicity for each patient
6 months

Study Arms (2)

non platinum based chemotherapy

EXPERIMENTAL

a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression

Drug: stealth liposomal doxorubicinDrug: carboplatinDrug: paclitaxelDrug: TopotecanDrug: Gemcitabine

platinum based chemotherapy

ACTIVE COMPARATOR

platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression

Drug: stealth liposomal doxorubicinDrug: carboplatinDrug: paclitaxelDrug: TopotecanDrug: Gemcitabine