- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973101
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)
July 14, 2014 updated by: Instituto do Cancer do Estado de São Paulo
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.
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Del Pilar Estevez Diz, MD
- Phone Number: 55 11 3893-2000
- Email: pesquisa.clinica@icesp.org.br
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Recruiting
- ICESP
-
Contact:
- Maria Del Pilar Estevez Diz, MD
- Phone Number: 55 11 3893-2000
- Email: pesquisa.clinica@icesp.org.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
|
50 mg/m2 - Day 1
Gemcitabine 1000mg/m2 on day 1 and day 8.
45 Gy
80 Gy
|
Active Comparator: Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
|
45 Gy
80 Gy
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: From the randomization until the end of the treatment - up to 36 month.
|
From the randomization until the end of the treatment - up to 36 month.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: 36 month after the end of the treatment.
|
36 month after the end of the treatment.
|
Locoregional disease control rate
Time Frame: 36 month after the end of treatment.
|
36 month after the end of treatment.
|
Acute and chronic toxicity in both arms
Time Frame: From the randomization until the end of the treatment.
|
From the randomization until the end of the treatment.
|
Overall survival
Time Frame: 36 month after the end of the treatment.
|
36 month after the end of the treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Del Pilar Estevez Diz, MD, Instituto do Cancer do Estado de Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nunes de Arruda F, da Costa S, Bonadio R, Dornellas A, Pereira D, de Bock GH, Del Pilar Estevez Diz M. Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial. Int J Gynecol Cancer. 2020 Jun;30(6):749-756. doi: 10.1136/ijgc-2019-001134. Epub 2020 Apr 21.
- da Costa SCS, Bonadio RC, Gabrielli FCG, Aranha AS, Dias Genta MLN, Miranda VC, de Freitas D, Abdo Filho E, Ferreira PAO, Machado KK, Scaranti M, Carvalho HA, Estevez-Diz MDP. Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation Versus Chemoradiation for Locally Advanced Cervical Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 Nov 20;37(33):3124-3131. doi: 10.1200/JCO.19.00674. Epub 2019 Aug 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
October 22, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (Estimate)
October 31, 2013
Study Record Updates
Last Update Posted (Estimate)
July 15, 2014
Last Update Submitted That Met QC Criteria
July 14, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- NP 217/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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