HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorInstituto Nacional de Cancerologia de Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HIPEC

    Procedure/Surgery

    Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: HIPEC groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.

Time frame
Up to 1 year
2

Impact of quality of life

To evaluate the impact on patients' quality of life, which is undergoing intraperitoneal hyperthermic chemotherapy during interval laparotomy. The scales that will be used will be EORTC QLQ-C30 (Ver. 3) and EORTC QLQ-OV28.

Time frame
Up to 1 year
3

Morbility

To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.

Time frame
Up to 1 year

Secondary outcomes

1

Disease free survival

Evaluate disease-free survival.

Time frame
Up to 2 years
2

Overall survival

Evaluate overall 5 year survival.

Time frame
up to five years

Other outcomes

Sponsors and contacts

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