Ovarian CancerPhase 3NCT00426257
Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer
A Phase 3 study testing Secondary debulking and secondary debulking with intraperitoneal chemotherapy in people with Ovarian Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 76 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Secondary debulking and secondary debulking with intraperitoneal chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2007to 16 Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 24Show fewer
- 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)
- In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:
- Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
- General criteria:
- Fit for major surgery, ASA 1 or ASA 2
- WHO performance status 0-2
- Written informed consent
- Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance > 60 ml/min (Cockroft formula); white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l
- For quality of life studies:
- Baseline questionnaires should be filled in before randomization
Who cannot join
- History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.
Read the detailed description
Rationale: Ovarian cancer is the second most common gynaecologic cancer in the Netherlands preceded by endometrial cancer. It is however the leading cause of death among women with gynaecologic malignancies with an annual mortality rate of 9 per 100.000. The majority of the patients are diagnosed with a high stage ovarian carcinoma due to the fact that symptoms occur at a late stage of the disease and screening methods for ovarian cancer are suboptimal. Optimal treatment consists of a combination of chemotherapy and debulking surgery. Despite the appearance of localized disease and the absence of obvious residual tumour following primary treatment, the majority of patients (80%) will have persistent disease or will develop recurrent disease. Additional strategies are warranted to reduce the recurrence rate and increase disease free survival and overall survival in this group of patients.
The concept of administering intraperitoneal chemotherapy is based on the ideas on peritoneal dialysis. Intraperitoneal drug therapy is designed to maximize drug delivery to the tumour with generally acceptable systemic side effects associated with IV administration of the drug. This strategy is especially attractive for treatment of ovarian carcinoma, which remains largely restricted to the abdominal cavity for most of its natural history. So far 3 randomised controlled trials have shown an overall and progression-free survival benefit when cisplatin is administered postoperatively by the IP route in patients with stage III, optimally resected disease. These studies however found that the majority of patients did not complete all planned 6 cycles due to catheter related problems. An alternative way of administering chemotherapy intra abdominally whilst bypassing the use of a catheter intra- abdominally is provided by perfusion of the abdomen during surgery under hyperthermic conditions. This study compares the interval debulking plus or minus the perfusion of the abdomen with chemotherapy under hyperthermic conditions during surgery (OVHIPEC).
Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms.
Secondary objectives of this study involve toxicity and morbidity, quality of life, tumour response following treatment and overall survival of the study arm compared to the standard arm.
Study design: Phase III randomised trial Study population: Patients diagnosed with stage III ovarian carcinoma, peritoneal cell carcinoma or tuba carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy. Age between 18 - 76 yr old.
Intervention: One group undergoes interval debulking with hyperthermic perfusion of the abdominal cavity with cisplatin 100 mg/m2 at the end of surgery. The other group is treated by interval debulking only.
Main study parameters/endpoints: Recurrence free survival Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants of the study will be asked to fill in quality of life questionnaires (12 times in 2 year). Blood samples will be taken following written informed consent before treatment, during surgery and during follow-up visits for marker studies and proteomics studies (10 times during 2 year). For patients participating in the pharmacokinetic studies (20) 2 tissue samples will be taken from the abdominal cavity during surgery and blood samples will be taken 6 times during and after surgery.
During follow-up 3 monthly visits will be scheduled in the first 2 years and 6-monthly visits during year 3-5. During these follow-up visits routine physical exam including pelvic exam and vaginal ultrasound (optional) is performed. CT-scans will be performed in the first 2 years before randomisation and 4 times at follow-up.
Risks of participating in this trial are related to the abdominal perfusion of cisplatin. This can cause systemic effects such as: nephrotoxicity, bone marrow toxicity, neurotoxicity, and longer hospital stay. It can also increase the chance on bowel perforation of a bowel anastomoses resulting in a longer hospital stay and possibly surgical intervention. To prevent systemic side effects of intra-abdominally administered cisplatin, sodium thiosulphate is administered intravenously during surgery.
- Conditions
- Ovarian Cancer
- Being tested
- Secondary debulking, secondary debulking with intraperitoneal chemotherapy
- Keywords
- Ovarian Cancer, stage III, hyperthermic intraperitoneal chemotherapy, debulking surgery, HIPEC
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary debulkingProcedure or surgery
Secondary debulking
secondary debulking with intraperitoneal chemotherapyProcedure or surgery
secondary debulking with intraperitoneal chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Secondary debulking surgery with hyperthermic intraperitoneal chemotherapy Receives: Procedure: secondary debulking with intraperitoneal chemotherapy |
| 2 | Active comparator | Secondary debulking surgery Receives: Procedure: Secondary debulking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of recurrence free survival.
Secondary outcomes (4)
Toxicity and morbidity
Quality of life
Tumour response
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Willemien J van Driel, MD, Study chair, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426257
- Sponsor's protocol ID
- M06OVH-OVHIPEC
- Other IDs
- 2006-003466-34, 2006-16
- Status last verified
- Aug 2017
- First submitted
- 23 Jan 2007
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38866963Aronson 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.
PubMed 37708912Ubachs 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.
PubMed 33019981Koole 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.
PubMed 31251694Koole 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.
PubMed 31128948van 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.
PubMed 29342393
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT00426257
- Acronym / sponsor ID
- M06OVH-OVHIPEC
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, stage III, hyperthermic intraperitoneal chemotherapy, debulking surgery, HIPEC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.
Detailed description
Rationale: Ovarian cancer is the second most common gynaecologic cancer in the Netherlands preceded by endometrial cancer. It is however the leading cause of death among women with gynaecologic malignancies with an annual mortality rate of 9 per 100.000. The majority of the patients are diagnosed with a high stage ovarian carcinoma due to the fact that symptoms occur at a late stage of the disease and screening methods for ovarian cancer are suboptimal. Optimal treatment consists of a combination of chemotherapy and debulking surgery. Despite the appearance of localized disease and the absence of obvious residual tumour following primary treatment, the majority of patients (80%) will have persistent disease or will develop recurrent disease. Additional strategies are warranted to reduce the recurrence rate and increase disease free survival and overall survival in this group of patients.
The concept of administering intraperitoneal chemotherapy is based on the ideas on peritoneal dialysis. Intraperitoneal drug therapy is designed to maximize drug delivery to the tumour with generally acceptable systemic side effects associated with IV administration of the drug. This strategy is especially attractive for treatment of ovarian carcinoma, which remains largely restricted to the abdominal cavity for most of its natural history. So far 3 randomised controlled trials have shown an overall and progression-free survival benefit when cisplatin is administered postoperatively by the IP route in patients with stage III, optimally resected disease. These studies however found that the majority of patients did not complete all planned 6 cycles due to catheter related problems. An alternative way of administering chemotherapy intra abdominally whilst bypassing the use of a catheter intra- abdominally is provided by perfusion of the abdomen during surgery under hyperthermic conditions. This study compares the interval debulking plus or minus the perfusion of the abdomen with chemotherapy under hyperthermic conditions during surgery (OVHIPEC).
Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms.
Secondary objectives of this study involve toxicity and morbidity, quality of life, tumour response following treatment and overall survival of the study arm compared to the standard arm.
Study design: Phase III randomised trial Study population: Patients diagnosed with stage III ovarian carcinoma, peritoneal cell carcinoma or tuba carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy. Age between 18 - 76 yr old.
Intervention: One group undergoes interval debulking with hyperthermic perfusion of the abdominal cavity with cisplatin 100 mg/m2 at the end of surgery. The other group is treated by interval debulking only.
Main study parameters/endpoints: Recurrence free survival Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants of the study will be asked to fill in quality of life questionnaires (12 times in 2 year). Blood samples will be taken following written informed consent before treatment, during surgery and during follow-up visits for marker studies and proteomics studies (10 times during 2 year). For patients participating in the pharmacokinetic studies (20) 2 tissue samples will be taken from the abdominal cavity during surgery and blood samples will be taken 6 times during and after surgery.
During follow-up 3 monthly visits will be scheduled in the first 2 years and 6-monthly visits during year 3-5. During these follow-up visits routine physical exam including pelvic exam and vaginal ultrasound (optional) is performed. CT-scans will be performed in the first 2 years before randomisation and 4 times at follow-up.
Risks of participating in this trial are related to the abdominal perfusion of cisplatin. This can cause systemic effects such as: nephrotoxicity, bone marrow toxicity, neurotoxicity, and longer hospital stay. It can also increase the chance on bowel perforation of a bowel anastomoses resulting in a longer hospital stay and possibly surgical intervention. To prevent systemic side effects of intra-abdominally administered cisplatin, sodium thiosulphate is administered intravenously during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: secondary debulking with intraperitoneal chemotherapySecondary debulking surgery with hyperthermic intraperitoneal chemotherapy |
| 2 | Active comparator | Procedure: Secondary debulkingSecondary debulking surgery |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- Patients eligible for interval debulking for the following 2 reasons:
Key exclusion criteria (1 listed)
- History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary debulkingSecondary debulking | Procedure or surgery | 2 |
| secondary debulking with intraperitoneal chemotherapysecondary debulking with intraperitoneal chemotherapy | Procedure or surgery | 1 |
Primary outcome
Duration of recurrence free survival.
4 secondary outcomes
Toxicity and morbidity
Quality of life
Tumour response
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Derived from this study: PubMed 38866963Aronson 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.
- Derived from this study: PubMed 37708912Aronson 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.
- Derived from this study: PubMed 33019981Ubachs 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.
- Derived from this study: PubMed 31251694Koole 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.
- Derived from this study: PubMed 31128948Koole 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.
- Derived from this study: PubMed 29342393van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willemien J van Driel, MD study chair
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secondary debulking and secondary debulking with intraperitoneal chemotherapy in people with Ovarian Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of recurrence free survival.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00426257, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.