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)

Instituto do Cancer do Estado de São Paulo

Status and phase: Unknown; Phase 2

Conditions: Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Treatments: Drug: Gemcitabine; Radiation: Brachytherapy; Drug: cisplatin; Radiation: Radiotherapy; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01973101

NP 217/2012

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Chemo-induction

Experimental group

Description:

Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Radiation: Radiotherapy

Radiation: Brachytherapy

Chemoradiotherapy

Active Comparator group

Description:

Cisplatin, radiotherapy and brachytherapy

Treatment:

Drug: cisplatin

Radiation: Radiotherapy

Radiation: Brachytherapy