Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix. (CIRCE)

July 14, 2014 updated by: Instituto do Cancer do Estado de São Paulo

Phase II, Prospective, Randomized, Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix.

The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Advanced carcinoma of uterine cervix histological confirmed.
  2. Indication for definitive chemoradiation treatment;
  3. Measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria;
  4. Age between 18 years old and 70 years old;
  5. Adequate bone marrow and organ function defined by laboratory values;
  6. Non evidence of disease in para-aortic lymph node;

Exclusion Criteria:

  1. Previous treatment with Chemotherapy or radiotherapy
  2. Previous surgery for primary tumor;
  3. Distant metastasis;
  4. Performance status according to Eastern Cooperative Oncology Group greater than 2;
  5. Peripheric neuropathy greater than grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 3.0;
  6. Significant Cardiac disease (history of and/or active disease);
  7. Other treatment for cancer, including hormonotherapy;
  8. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Drug: Cisplatin
50 mg/m2 - Day 1
Drug: Gemcitabine
Gemcitabine 1000mg/m2 on day 1 and day 8.
Radiation: Radiotherapy
45 Gy
Radiation: Brachytherapy
80 Gy
Active Comparator: Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
Radiation: Radiotherapy
45 Gy
Radiation: Brachytherapy
80 Gy
Drug: cisplatin
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: From the randomization until the end of the treatment - up to 36 month.
From the randomization until the end of the treatment - up to 36 month.

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 36 month after the end of the treatment.
36 month after the end of the treatment.
Locoregional disease control rate
Time Frame: 36 month after the end of treatment.
36 month after the end of treatment.
Acute and chronic toxicity in both arms
Time Frame: From the randomization until the end of the treatment.
From the randomization until the end of the treatment.
Overall survival
Time Frame: 36 month after the end of the treatment.
36 month after the end of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Maria Del Pilar Estevez Diz, MD, Instituto do Cancer do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 217/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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