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.
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
Keywords: Advanced carcinomas of uterine cervix
Chemoradiation
Chemo-induction
Cisplatin
Gemcitabine
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Disease free survival
timeFrame: From the randomization until the end of the treatment - up to 36 month.
Secondary outcomes:
measure: Response rate
timeFrame: 36 month after the end of the treatment.
measure: Locoregional disease control rate
timeFrame: 36 month after the end of treatment.
measure: Acute and chronic toxicity in both arms
timeFrame: From the randomization until the end of the treatment.
measure: Overall survival
timeFrame: 36 month after the end of the treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ICESP
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Maria Del Pilar Estevez Diz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.