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.

Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t Clinical Trial

— CIRCE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973101
• Other study ID #: NP 217/2012
• Status: Recruiting
• Phase: Phase 2
• First received: October 22, 2013
• Last updated: July 14, 2014
• Start date: June 2012
• Est. completion date: April 2017

Study information

• Verified date: July 2014
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Maria Del Pilar Estevez Diz, MD
• Phone: 55 11 3893-2000
• Email: pesquisa.clinica[@]icesp.org.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cisplatin
50 mg/m2 - Day 1
• Gemcitabine
Gemcitabine 1000mg/m2 on day 1 and day 8.
• cisplatin
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.

Radiation:
• Radiotherapy
45 Gy
• Brachytherapy
80 Gy

Locations

Country	Name	City	State
Brazil	ICESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		From the randomization until the end of the treatment - up to 36 month.	Yes
Secondary	Response rate		36 month after the end of the treatment.	Yes
Secondary	Locoregional disease control rate		36 month after the end of treatment.	Yes
Secondary	Acute and chronic toxicity in both arms		From the randomization until the end of the treatment.	Yes
Secondary	Overall survival		36 month after the end of the treatment.	Yes