Patients Diagnosed With Advanced Carcinoma of Uterine Cervix tPhase 2CIRCENCT01973101
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.
A Phase 2 study testing Cisplatin, Gemcitabine and Radiotherapy in people with Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
- What is being tested?
- Cisplatin, Gemcitabine and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ICESP
São Paulo, São Paulo
Maria Del Pilar Estevez Diz, MD, 55 11 3893-2000, pesquisa.clinica@icesp.org.br
About this study
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.
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.
- Being tested
- Cisplatin, Gemcitabine, Radiotherapy, Brachytherapy
- Keywords
- Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
50 mg/m2 - Day 1
GemcitabineDrug
Gemcitabine 1000mg/m2 on day 1 and day 8.
cisplatinDrug
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
RadiotherapyRadiation
45 Gy
BrachytherapyRadiation
80 Gy
| Study group | Role | What they receive |
|---|---|---|
| Chemo-induction | Experimental | Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy Receives: Drug: Cisplatin; Drug: Gemcitabine; Radiation: Radiotherapy; Radiation: Brachytherapy |
| Chemoradiotherapy | Active comparator | Cisplatin, radiotherapy and brachytherapy Receives: Drug: cisplatin; Radiation: Radiotherapy; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: From the randomization until the end of the treatment - up to 36 month.
Secondary outcomes (4)
Response rate
Measured: 36 month after the end of the treatment.
Locoregional disease control rate
Measured: 36 month after the end of treatment.
Acute and chronic toxicity in both arms
Measured: From the randomization until the end of the treatment.
Overall survival
Measured: 36 month after the end of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Diagnosed With Advanced Carcinoma of Uterine Cervix tStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Del Pilar Estevez Diz, MD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973101
- Sponsor's protocol ID
- NP 217/2012
- Acronym
- CIRCE
- Status last verified
- Jul 2014
- First submitted
- 22 Oct 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
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.
PubMed 32321767da 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.
PubMed 31449470
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01973101
- Acronym / sponsor ID
- CIRCE / NP 217/2012
- Keywords
- Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo-induction | Experimental | Drug: Cisplatin, Drug: Gemcitabine, Radiation: Radiotherapy, Radiation: BrachytherapyCisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy |
| Chemoradiotherapy | Active comparator | Drug: cisplatin, Radiation: Radiotherapy, Radiation: BrachytherapyCisplatin, radiotherapy and brachytherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin50 mg/m2 - Day 1 | Drug | Chemo-induction |
| GemcitabineGemcitabine 1000mg/m2 on day 1 and day 8. | Drug | Chemo-induction |
| cisplatinCisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period. | Drug | Chemo-induction, Chemoradiotherapy |
| Radiotherapy45 Gy | Radiation | Chemo-induction, Chemoradiotherapy |
| Brachytherapy80 Gy | Radiation | Chemo-induction, Chemoradiotherapy |
Primary outcome
Disease free survival
Time frame: From the randomization until the end of the treatment - up to 36 month.
4 secondary outcomes
Response rate
Time frame: 36 month after the end of the treatment.
Locoregional disease control rate
Time frame: 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.
Overall survival
Time frame: 36 month after the end of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Derived from this study: PubMed 32321767Nunes 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.
- Derived from this study: PubMed 31449470da 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Del Pilar Estevez Diz, MD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Gemcitabine and Radiotherapy in people with Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Del Pilar Estevez Diz, MD (55 11 3893-2000, pesquisa.clinica@icesp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From the randomization until the end of the treatment - up to 36 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.