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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01973101
First Posted: October 31, 2013
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
  Purpose
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.

Condition Intervention Phase
Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t Drug: Cisplatin Drug: Gemcitabine Drug: cisplatin Radiation: Radiotherapy Radiation: Brachytherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: From the randomization until the end of the treatment - up to 36 month. ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 36 month after the end of the treatment. ]
  • Locoregional disease control rate [ Time Frame: 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. ]
  • Overall survival [ Time Frame: 36 month after the end of the treatment. ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: cisplatin
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
Radiation: Radiotherapy
45 Gy
Radiation: Brachytherapy
80 Gy
Active Comparator: Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
Drug: cisplatin
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
Radiation: Radiotherapy
45 Gy
Radiation: Brachytherapy
80 Gy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973101


Contacts
Contact: Maria Del Pilar Estevez Diz, MD 55 11 3893-2000 pesquisa.clinica@icesp.org.br

Locations
Brazil
ICESP Recruiting
São Paulo, SP, Brazil
Contact: Maria Del Pilar Estevez Diz, MD    55 11 3893-2000    pesquisa.clinica@icesp.org.br   
Sponsors and Collaborators
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
  More Information

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01973101     History of Changes
Other Study ID Numbers: NP 217/2012
First Submitted: October 22, 2013
First Posted: October 31, 2013
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Advanced carcinomas of uterine cervix
Chemoradiation
Chemo-induction
Cisplatin
Gemcitabine

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs