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MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer

NCT00326456 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2023-03-27

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer.

Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.

Conditions

Interventions

DRUG

liposomal doxorubicin

30 mg/m2 gieven intravenously on day 1 every 3 weeks

DRUG

carboplatin

AUC 5 intravenously on day 1 every 3 weeks

DRUG

paclitaxel

175 mg/m2 intravenously on day 1 every 3 weeks

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, M.D., Ph.D · National Cancer Institute, Naples

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute, Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy
  • Portugal
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326456 on ClinicalTrials.gov