NCT00426257

Brief Summary

This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2017

Enrollment Period

10.5 years

First QC Date

January 23, 2007

Last Update Submit

August 22, 2018

Conditions

Ovarian Cancer

Keywords

Ovarian Cancerstage IIIhyperthermic intraperitoneal chemotherapydebulking surgeryHIPEC

Outcome Measures

Primary Outcomes (1)

  • Duration of recurrence free survival.

Secondary Outcomes (4)

  • Toxicity and morbidity

  • Quality of life

  • Tumour response

  • Overall survival

Study Arms (2)

1

EXPERIMENTAL

Secondary debulking surgery with hyperthermic intraperitoneal chemotherapy

Procedure: secondary debulking with intraperitoneal chemotherapy

2

ACTIVE COMPARATOR

Secondary debulking surgery

Procedure: Secondary debulking

Interventions

Secondary debulkingPROCEDURE

Secondary debulking

2
secondary debulking with intraperitoneal chemotherapyPROCEDURE

secondary debulking with intraperitoneal chemotherapy

1

Eligibility Criteria

Age18 Years - 76 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 76 years
  • Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma.
  • In case of pleural effusion cytology should be negative for tumour cells
  • In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:
  • Normal mammogram (\< 6 weeks before first registration) and
  • Presence of pelvic mass and
  • CA 125 \> 200 kU/l and
  • Serum CA125/CEA ratio \> 25. If the serum CA125/CEA ratio is \< 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (\< 6 weeks before registration) and
  • Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
  • Patients eligible for interval debulking for the following 2 reasons:
  • Primary debulking surgery not feasible due to tumour extension or general condition (patients treated by primary chemotherapy) or
  • Incomplete primary debulking with residual disease \> 1 cm
  • In case of primary chemotherapy:
  • Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
  • Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Related Publications (6)

  • Aronson SL, Walker C, Thijssen B, van de Vijver KK, Horlings HM, Sanders J, Alkemade M, Koole SN, Lopez-Yurda M, Lok CAR; OVHIPEC-1 Study Group; Rottenberg S, van Rheenen J, Sonke GS, van Driel WJ, Kester LA, Hahn K. Tumour microenvironment characterisation to stratify patients for hyperthermic intraperitoneal chemotherapy in high-grade serous ovarian cancer (OVHIPEC-1). Br J Cancer. 2024 Aug;131(3):565-576. doi: 10.1038/s41416-024-02731-6. Epub 2024 Jun 12.

    PMID: 38866963DERIVED

  • Aronson SL, Lopez-Yurda M, Koole SN, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van Gent MDJM, Arts HJG, van Ham MAPC, van Dam PA, Vuylsteke P, Aalbers AGJ, Verwaal VJ, Van de Vijver KK, Aaronson NK, Sonke GS, van Driel WJ. Cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer (OVHIPEC-1): final survival analysis of a randomised, controlled, phase 3 trial. Lancet Oncol. 2023 Oct;24(10):1109-1118. doi: 10.1016/S1470-2045(23)00396-0. Epub 2023 Sep 11.

    PMID: 37708912DERIVED

  • Ubachs J, Koole SN, Lahaye M, Fabris C, Bruijs L, Schagen van Leeuwen J, Schreuder HWR, Hermans RH, de Hingh IH, van der Velden J, Arts HJ, van Ham M, van Dam P, Vuylsteke P, Bastings J, Kruitwagen RFPM, Lambrechts S, Olde Damink SWM, Rensen SS, Van Gorp T, Sonke GS, van Driel WJ. No influence of sarcopenia on survival of ovarian cancer patients in a prospective validation study. Gynecol Oncol. 2020 Dec;159(3):706-711. doi: 10.1016/j.ygyno.2020.09.042. Epub 2020 Oct 2.

    PMID: 33019981DERIVED

  • Koole SN, van Lieshout C, van Driel WJ, van Schagen E, Sikorska K, Kieffer JM, Schagen van Leeuwen JH, Schreuder HWR, Hermans RH, de Hingh IH, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AG, Verwaal VJ, Van de Vijver KK, Aaronson NK, van Tinteren H, Sonke GS, van Harten WH, Retel VP. Cost Effectiveness of Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer on the Basis of a Randomized Phase III Trial. J Clin Oncol. 2019 Aug 10;37(23):2041-2050. doi: 10.1200/JCO.19.00594. Epub 2019 Jun 28.

    PMID: 31251694DERIVED

  • Koole SN, Kieffer JM, K Sikorska, Schagen van Leeuwen JH, Schreuder HWR, Hermans RH, de Hingh IH, van der Velden J, Arts HJ, van Ham MAPC, Aalbers AG, Verwaal VJ, Van de Vijver KK, Sonke GS, van Driel WJ, Aaronson NK. Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer. Eur J Surg Oncol. 2021 Jan;47(1):101-107. doi: 10.1016/j.ejso.2019.05.006. Epub 2019 May 13.

    PMID: 31128948DERIVED

  • van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.

    PMID: 29342393DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Willemien J van Driel, MD

    The Netherlands Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

February 1, 2007

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

August 24, 2018

Record last verified: 2017-08

Locations

NL(1)