Ovarian Cancer RecurrentNCT03717610
Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer
A study testing radical surgery with HIPEC in people with Ovarian Cancer Recurrent, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- radical surgery with HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2018to 31 Dec 2022
- Phase
- Interventional
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
- ECOG/WHO Performance score of 0 to 1
- Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula)
- Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
- Histological types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma
- No end organ function
- Patients must have less than or equal to 2.5 mm residual disease at the completion of the cytoreductive surgery to be eligible for the study
- Patient-compliant and psychologically able to follow the trial procedures, signature of informed consent.
Who cannot join
- Evidence of extensive retroperitoneal lymph node disease
- Neuropsychiatric disorders;
- Pregnancy or breast feeding.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
- Subjects with active infection that requires parenteral antibiotics
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- Tumors of low malignant potential, or non-invasive borderline tumors
- Patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study
- Patient with extra-abdominal metastatic disease
- Known platinum (carboplatin or cisplatin) allergy
- Life expectancy < 3 months
- Still, it will not be considered for the HIPEC protocol those patients with unresectable disease (presence of invasive peritoneal implants inoperable or at high risk for resection in critical locations such as hepatic hilum, the mesenteric root, trunk celiac, mesentery, and several small implants the serosa of the small intestine) and / or with residual disease after cytoreduction greater than or equal to 2.5 mm (CC-2 and CC-3).
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hopsital
Uppsala, 75185
Marta Lomnytska, PhD, 018-611 00 00 ext. +46, marta.lomnytska@akademiska.se
Ilvars Silins, PhD, 018-611 00 00 ext. +46, ilvars.silins@akademiska.se
About this study
Official title: Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers
This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.
Read the detailed description
Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC.
Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- radical surgery with HIPEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical surgery with HIPECProcedure or surgery
Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).
| Study group | Role | What they receive |
|---|---|---|
| Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min | Experimental | Not described Receives: Procedure: radical surgery with HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related toxicities
Registration of the effects according to NCI CTCAEv4.0 guidelines.
Measured: 3 months after surgery
Secondary outcomes (5)
Assessment of quality of life
EORTC C30 quality of life questionnaire
Measured: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of life in relation to ovarian cancer
EORTC OV28 quality of life questionnaire
Measured: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of Life in relation to eventually performed intestinal surgery
EORTC CR29 quality of life questionnaire
Measured: before surgery, and 4 weeks, 3 months and 6 months after surgery
Morbidity
Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale
Measured: 30 days after surgery
Mortality
Number of participants with lethal outcome
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start4 Oct 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Marta Lomnytska, Uppsala University Hospital
- Investigators
- Marta Lomnytska, MD, PhD, Principal investigator, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717610
- Sponsor's protocol ID
- 077/2018
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2018
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers
- ClinicalTrials.gov ID
- NCT03717610
- Acronym / sponsor ID
- 077/2018
- Conditions
- Ovarian Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University, The Netherlands Cancer Institute
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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 is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.
Detailed description
Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC.
Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min | Experimental | Procedure: radical surgery with HIPEC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
- ECOG/WHO Performance score of 0 to 1
- Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula)
- Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
- Histological types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma
Key exclusion criteria (12 listed)
- Evidence of extensive retroperitoneal lymph node disease
- Neuropsychiatric disorders;
- Pregnancy or breast feeding.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
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 |
|---|---|---|
| radical surgery with HIPECStraight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C). | Procedure or surgery | Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min |
Primary outcome
Treatment-related toxicities
Time frame: 3 months after surgery
Registration of the effects according to NCI CTCAEv4.0 guidelines.
5 secondary outcomes
Assessment of quality of life
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of life in relation to ovarian cancer
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of Life in relation to eventually performed intestinal surgery
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Morbidity
Time frame: 30 days after surgery
Mortality
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Marta Lomnytska, MD, PhD principal investigator
Uppsala University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radical surgery with HIPEC in people with Ovarian Cancer Recurrent, run by Uppsala University Hospital at 1 site in Sweden.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Oct 2021. 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 Sweden. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Lomnytska, MD, PhD (018-611 00 00 ext. +46, marta.lomnytska@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related toxicities (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.