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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)

Primary Purpose

Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cisplatin
Gemcitabine
cisplatin
Radiotherapy
Brachytherapy
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t focused on measuring Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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;

Sites / Locations

  • ICESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemo-induction

Chemoradiotherapy

Arm Description

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

Cisplatin, radiotherapy and brachytherapy

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Response rate
Locoregional disease control rate
Acute and chronic toxicity in both arms
Overall survival

Full Information

First Posted
October 22, 2013
Last Updated
July 14, 2014
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01973101
Brief Title
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.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
Keywords
Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemo-induction
Arm Type
Experimental
Arm Description
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Arm Title
Chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Cisplatin, radiotherapy and brachytherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
50 mg/m2 - Day 1
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000mg/m2 on day 1 and day 8.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
45 Gy
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
80 Gy
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
From the randomization until the end of the treatment - up to 36 month.
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
36 month after the end of the treatment.
Title
Locoregional disease control rate
Time Frame
36 month after the end of treatment.
Title
Acute and chronic toxicity in both arms
Time Frame
From the randomization until the end of the treatment.
Title
Overall survival
Time Frame
36 month after the end of the treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Del Pilar Estevez Diz, MD
Phone
55 11 3893-2000
Email
pesquisa.clinica@icesp.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Del Pilar Estevez Diz, MD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICESP
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Del Pilar Estevez Diz, MD
Phone
55 11 3893-2000
Email
pesquisa.clinica@icesp.org.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
32321767
Citation
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.
Results Reference
derived
PubMed Identifier
31449470
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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