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 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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01973101

Acronym

CIRCE

Enrollment

120

Registered

2013-10-31

Start date

2012-06-30

Completion date

2017-04-30

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Keywords

Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine

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.

Interventions

DRUGCisplatin

50 mg/m2 - Day 1

DRUGGemcitabine

Gemcitabine 1000mg/m2 on day 1 and day 8.

DRUGcisplatin

Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.

RADIATIONRadiotherapy

45 Gy

RADIATIONBrachytherapy

80 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

Brazil

Contacts

Primary ContactMaria Del Pilar Estevez Diz, MD

pesquisa.clinica@icesp.org.br55 11 3893-2000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026