MedTrace Logo

4 Versus 6 Courses of Adjuvant Chemotherapy in LACC Patients Previously Treated With NACT Plus Radical Surgery

NCT02365935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2015-02-19

No results posted yet for this study

Summary

The investigators primary outcome was to evaluate the effectiveness in term of Overall Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB) previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS).

The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of the two treatment options.

Conditions

  • Uterine Cervical Neoplasms

Interventions

PROCEDURE

Group A adjuvant chemotherapy

In Group A, all patients received 4 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.

PROCEDURE

Group B adjuvant chemotherapy

In Group B, all patients received 6 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.

DRUG

Cisplatin

DRUG

Paclitaxel

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Roberto Angioli, Professor · Campus Bio Medico of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-01-31
Completion
2014-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT02365935 on ClinicalTrials.gov