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NCT Number: NCT03772028

Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Rigshospitalet Copenhagen, Copenhagen, Denmark

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About this study

The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • candidate for primary CRS
  • histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion criteria

  • history of previous malignancies within 5 years prior to inclusion
  • FIGO stage IV disease
  • complete primary cytoreduction is impossible
  • prior treatment for the current malignancy

Treatment and study plan

Cisplatin

Drug

HIPEC with cisplatin after cytoreductive surgery

Primary outcomes

  1. overall survival

    Time frame: 1 year after last patient last visit

Secondary outcomes

  1. recurrence-free survival

    Time frame: 1 year after last patient last visit

  2. adverse events

    Time frame: 30 days after end of treatment

    toxicity of extra treatment compared standaard treatment

  3. cost evaluation

    Time frame: 1 year after lplv

    cost evaluation based measured by quality adjusted life year

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Acronym: OVHIPEC-2

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2018
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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