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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01973101
First received: October 22, 2013
Last updated: July 14, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 36 month after the end of the treatment. ] [ Designated as safety issue: Yes ]
  • Locoregional disease control rate [ Time Frame: 36 month after the end of treatment. ] [ Designated as safety issue: Yes ]
  • Acute and chronic toxicity in both arms [ Time Frame: From the randomization until the end of the treatment. ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 36 month after the end of the treatment. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01973101     History of Changes
Other Study ID Numbers: NP 217/2012
Study First Received: October 22, 2013
Last Updated: July 14, 2014
Health Authority: Brazil: Ethics Committee

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:
Uterine Cervical Diseases
Carcinoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014