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New treatment option for HPEC
Official title HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
ClinicalTrials.gov ID: NCT03275194
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- Signature of informed consent.
You likely can't join if
- Patients with heart failure, ischemic heart disease
- Previous history of treatment with chemotherapy for some other neoplasia
- History of neuropsychiatric disease
- Patients with intra operative bleeding that condition hemodynamic instability.
- Patient requiring more than 2 intraoperative anastomosis
See the full eligibility criteria
- 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: a) Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this...
- Patients with heart failure, ischemic heart disease
- Previous history of treatment with chemotherapy for some other neoplasia
- History of neuropsychiatric disease
- Patients with intra operative bleeding that condition hemodynamic instability.
- Patient requiring more than 2 intraoperative anastomosis
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.