CIRCE: 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.

Sponsor

Instituto do Cancer do Estado de São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01973101

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

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.

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

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. 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

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.

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

Outcome Measures

Primary Outcome Measures

Disease free survival [From the randomization until the end of the treatment - up to 36 month.]

Secondary Outcome Measures

Response rate [36 month after the end of the treatment.]
Locoregional disease control rate [36 month after the end of treatment.]
Acute and chronic toxicity in both arms [From the randomization until the end of the treatment.]
Overall survival [36 month after the end of the treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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