Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
NCT ID: NCT02328716
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
32 participants
INTERVENTIONAL
2012-02-29
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT01767675
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
NCT03275194
Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer
NCT03717610
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
NCT01970722
Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
NCT05415709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Comparator
Comparator
Cytoreduction
Cytoreduction
Experimental
Experimental
Cytoreduction
Cytoreduction
Hipec with Cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cytoreduction
Cytoreduction
Hipec with Cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Residual tumor \< 2.5 mm after completion of cytoreductive surgery.
* Aged \< 75 years.
* Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
* Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
* Adequate renal function with creatinine ? 1.5 mg/ dl.
* Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
* Optimal cardiopulmonary function.
* In recurrences, disease-free interval \> 6 months.
* Voluntary and signed written informed consent.
Exclusion Criteria
* Suboptimal debulking (residual tumor \> 2.5 mm).
* Previous history of other malignancies (excluding skin)
* Intestinal obstruction at the time of evaluation.
* Renal failure.
* Heart failure.
* Uncontrolled infection.
* Pregnant or lactating patients.
* In recurrences, disease-free interval \< 6 months.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pedro Cascales Campos, M.D Phd
Role: STUDY_DIRECTOR
Hospital Universitario Virgen de la Arrixaca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Pedro Cascales Campos, MD,PhD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Pedro Cascales Campos
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Cascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-001715-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EC-GC/AD-01/11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.