NCT01973101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

4.8 years

First QC Date

October 22, 2013

Last Update Submit

July 14, 2014

Conditions

Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Keywords

Advanced carcinomas of uterine cervixChemoradiationChemo-inductionCisplatinGemcitabine

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    From the randomization until the end of the treatment - up to 36 month.

Secondary Outcomes (4)

  • 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.

Study Arms (2)

Chemo-induction

EXPERIMENTAL

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

Drug: CisplatinDrug: GemcitabineRadiation: RadiotherapyRadiation: Brachytherapy

Chemoradiotherapy

ACTIVE COMPARATOR

Cisplatin, radiotherapy and brachytherapy

Drug: cisplatinRadiation: RadiotherapyRadiation: Brachytherapy

Interventions

cisplatinDRUG

50 mg/m2 - Day 1

Chemo-induction
GemcitabineDRUG

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

Chemo-induction
RadiotherapyRADIATION

45 Gy

Chemo-inductionChemoradiotherapy
BrachytherapyRADIATION

80 Gy

Chemo-inductionChemoradiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICESP

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32321767DERIVED

  • 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.

    PMID: 31449470DERIVED

MeSH Terms

Interventions

CisplatinGemcitabineRadiotherapyBrachytherapy

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Maria Del Pilar Estevez Diz, MD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Del Pilar Estevez Diz, MD

CONTACT

55 11 3893-2000pesquisa.clinica@icesp.org.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 31, 2013

Study Start

June 1, 2012

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

BR(1)