NCT03275194RecruitingPhase 2
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study
Source: ClinicalTrials.gov · Last updated 28 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Ovarian cancer is the leading cause of gynecological cancer mortality, with no current screening method effective for early diagnosis, with 75% of advanced stage patients being detected. Not all patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Sept 2017
- Start date
- 2 Sept 2017
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Diseases
- Ovarian cancer
- NCT number
- NCT03275194
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 2 Sept 2017 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of treatment with chemotherapy for some other neoplasia
Other illness
- Patients with heart failure, ischemic heart disease
- History of neuropsychiatric disease
- Patients with intra operative bleeding that condition hemodynamic instability.
Other
- Patient requiring more than 2 intraoperative anastomosis
Who the study is looking for
- Patients younger than 70 years
- Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
- Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
- Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
- Signature of informed consent.
- Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
- ECOG less than or equal to 1
- Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters:
- Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this hemoglobin level) b) Leukocytes Greater than 3000 / mm3 (c) Platelets equal to or greater than 100 000 / mm3 (d) total bilirubin less than 1.5 times greater than the normal value e) Hepatic transaminases less than 1.5 times higher than normal value f) Creatinine \<1.2 g / dl. In case of being elevated the measured purification should be greater than 60mL / min according to Cockroft's formula.
- Albumin greater than 3gr / dl. h) Left Ventricle Ejection fraction per cardiac echography greater than 55% 9). Sugarbaker carcinomatosis index less than 20
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute of Mexico Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.