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.

Phase 2

• Conditions: Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
• Interventions: Drug: cisplatin; Radiation: Radiotherapy; Drug: Gemcitabine; Radiation: Brachytherapy

• Registration Number: NCT01973101
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemo-induction	Brachytherapy	Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Chemoradiotherapy	Brachytherapy	Cisplatin, radiotherapy and brachytherapy
Chemoradiotherapy	Radiotherapy	Cisplatin, radiotherapy and brachytherapy
Chemo-induction	Radiotherapy	Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Chemoradiotherapy	cisplatin	Cisplatin, radiotherapy and brachytherapy
Chemo-induction	cisplatin	Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Chemo-induction	Gemcitabine	Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy

Primary Outcome Measures

Name	Time	Method
Disease free survival	From the randomization until the end of the treatment - up to 36 month.

Secondary Outcome Measures

Name	Time	Method
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.
Response rate	36 month after the end of the treatment.

Trial Locations

Locations (1)

ICESP; 🇧🇷 São Paulo, SP, Brazil