Stage III Ovarian CancerPhase 2CRS/HIPECNCT02124421
HOT: HIPEC in Ovarian Cancer as Initial Treatment
A Phase 2 study testing Cytoreductive Surgery (CRS), Adjuvant Chemotherapy and Questionnaire in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by Mercy Medical Center at 1 site in United States.
Trial summary
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Epithelial Ovarian Cancer
- What is being tested?
- Cytoreductive Surgery (CRS), Adjuvant Chemotherapy and Questionnaire
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
- Stage III/IV disease
- No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
- Histological confirmation
- Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
- ≤1 cm residual disease at the completion of the cytoreductive surgery (GOG criteria for optimally cytoreduction)
Show all 21Show fewer
- Bone marrow function:
- Absolute neutrophil count (ANC) ≥1,000/mm3
- Platelets ≥100,000/mm3
- Hemoglobin ≥ 8.5 g/dL
- Renal function:
- 1) Creatinine ≤1.5 times the upper limit of normal or a calculated creatinine clearance ≥60ml/min
- Hepatic function:
- Bilirubin ≤1.5 times upper limit of normal
- Alanine aminotransferase (ALT) ≤3 times upper limit of normal
- Aspartate aminotransferase (AST) ≤3 times upper limit of normal
- Blood coagulation parameters:
- Prothrombin time (PT) with International Normalized Ratio of ≤1.5 and a partial prothrombin time (PTT) ≤1.5 times upper limit of normal
- For patients on full dose warfarin, in range International Normalized Ratio (usually between 2 and 3) and
- Partial prothrombin time (PTT) <1.2 times upper limit of normal
- Candidate for administration of postoperative standard platinum-based combination systemic chemotherapy (adequate bone marrow, renal, hepatic function, and blood coagulation parameters)
Who cannot join
- Any prior treatment modality for the diagnosis of ovarian, fallopian tube, or primary peritoneal cancerPrior surgical attempt of cytoreductive surgery
- Stage I/II disease
- Presence of other invasive malignancies or evidence of other cancer within the past 3 years
- Known active acute hepatitis and confirmed diagnosis of HIV
- Active systemic infection that requires use of parenteral antibiotics
- History of acute coronary syndromes (ACS), within the last 6 months, according to AHA definitions
Show all 14Show fewer
- New York Heart Association (NYHA) Class II or higher congestive heart failure according to American Heart Association (AHA) definitions
- Canadian Cardiovascular Society (CCS) Class II or higher angina grade according to AHA definitions
- Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at time of consent by cardiologist
- History of cerebral artery disease and prior stroke according to AHA definitions in the last 6 months
- Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal or calculated creatinine clearance <60 ml/min
- Patients with concurrent severe medical problems unrelated to malignancy that will preclude compliance with the study or places at an unacceptable risk for participation in the study determinate by study investigators
- Pregnant women are excluded from this study because carboplatin is category D agent with the potential of teratogenic effects. Due to potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin, breastfeeding should be discontinued
- Life expectancy of < 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Read the detailed description
Primary endpoints:
- To assess the feasibility of recruitment
- Compare complication rates between the two study arms: CRS with HIPEC and CRS alone.
Secondary endpoints:
- To determine risk factors for morbidity and mortality
- Assess completion rate of 6 cycles of systemic chemotherapy
- To determine progression free survival at 24 months
- To determine overall survival at 1, 3, and 5 years
- Evaluate health related quality of life
Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy.
Twenty-four patients will undergo CRS with HIPEC performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175mg/m2) for 6 cycles postoperatively.
Twenty-four patients will undergo CRS only performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by IV/IP chemotherapy with Day 1: IV paclitaxel (135 mg/m2), Day 2: IP cisplatin (75 mg/m2), and Day 8: IP paclitaxel (60 mg/m2) for 6 cycles postoperatively.
- Conditions
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Ovarian Carcinoma
- Being tested
- Cytoreductive Surgery (CRS), Adjuvant Chemotherapy, Questionnaire, Hyperthermic intraperitoneal chemotherapy, Carboplatin
- Keywords
- Ovarian cancer, Cytoreductive surgery, Hyperthermic Intraperitoneal chemotherapy, Systemic chemotherapy, Primary peritoneal carcinoma, Fallopian Tube cancer, Intraperitoneal chemotherapy, IV/IP chemotherapy, IV chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive Surgery (CRS)Procedure or surgery
Also called CRS
Cytoreductive surgery
Adjuvant ChemotherapyDrug
Also called Post-operative chemotherapy, Systemic chemotherapy
Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
QuestionnaireOther
Also called FACT-O Questionnaire
Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
Hyperthermic intraperitoneal chemotherapyProcedure or surgery
Also called HIPEC
Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
CarboplatinDrug
Also called Paraplatin
AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
PaclitaxelDrug
Also called Taxol
175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
PaclitaxelDrug
Also called Taxol
Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
CisplatinDrug
Also called CDDP
Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| CRS with adjuvant IV/IP chemotherapy | Active comparator | Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up Receives: Procedure: Cytoreductive Surgery (CRS); Drug: Adjuvant Chemotherapy; Other: Questionnaire; Drug: Paclitaxel; Drug: Cisplatin |
| CRS/HIPEC with adjuvant IV chemotherapy | Experimental | Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up Receives: Procedure: Cytoreductive Surgery (CRS); Drug: Adjuvant Chemotherapy; Other: Questionnaire; Procedure: Hyperthermic intraperitoneal chemotherapy; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complication rates
Compare post-operative complication rates between study arms
Measured: 30 days post-operative
Secondary outcomes (3)
Assessment of quality of life
FACT-O questionnaire to assess quality of life in both study arms
Measured: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Evaluate the rate of progression free survival
Time from intervention to disease recurrence
Measured: at 24 months
Evaluate overall survival
Time from intervention to death
Measured: at 1, 3, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Ovarian CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Diaz-Montes, M.D., Principal investigator, Mercy Medical CenterArmando Sardi, M.D., Principal investigator, Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124421
- Sponsor's protocol ID
- MMC-2014-17
- Acronym
- CRS/HIPEC
- Status last verified
- Nov 2024
- First submitted
- 13 Apr 2014
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT02124421
- Acronym / sponsor ID
- CRS/HIPEC / MMC-2014-17
- Conditions
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Ovarian Carcinoma
- Keywords
- Ovarian cancer, Cytoreductive surgery, Hyperthermic Intraperitoneal chemotherapy, Systemic chemotherapy, Primary peritoneal carcinoma, Fallopian Tube cancer, Intraperitoneal chemotherapy, IV/IP chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 28 Apr 2014 (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.
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Detailed description
Primary endpoints:
- To assess the feasibility of recruitment
- Compare complication rates between the two study arms: CRS with HIPEC and CRS alone.
Secondary endpoints:
- To determine risk factors for morbidity and mortality
- Assess completion rate of 6 cycles of systemic chemotherapy
- To determine progression free survival at 24 months
- To determine overall survival at 1, 3, and 5 years
- Evaluate health related quality of life
Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy.
Twenty-four patients will undergo CRS with HIPEC performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175mg/m2) for 6 cycles postoperatively.
Twenty-four patients will undergo CRS only performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by IV/IP chemotherapy with Day 1: IV paclitaxel (135 mg/m2), Day 2: IP cisplatin (75 mg/m2), and Day 8: IP paclitaxel (60 mg/m2) for 6 cycles postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRS with adjuvant IV/IP chemotherapy | Active comparator | Procedure: Cytoreductive Surgery (CRS), Drug: Adjuvant Chemotherapy, Other: Questionnaire, Drug: Paclitaxel, Drug: CisplatinPatients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up |
| CRS/HIPEC with adjuvant IV chemotherapy | Experimental | Procedure: Cytoreductive Surgery (CRS), Drug: Adjuvant Chemotherapy, Other: Questionnaire, Procedure: Hyperthermic intraperitoneal chemotherapy, Drug: Carboplatin, Drug: PaclitaxelCytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
- Stage III/IV disease
- No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
- Histological confirmation
- Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Key exclusion criteria (14 listed)
- Any prior treatment modality for the diagnosis of ovarian, fallopian tube, or primary peritoneal cancerPrior surgical attempt of cytoreductive surgery
- Stage I/II disease
- Presence of other invasive malignancies or evidence of other cancer within the past 3 years
- Known active acute hepatitis and confirmed diagnosis of HIV
- Active systemic infection that requires use of parenteral antibiotics
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 |
|---|---|---|
| Cytoreductive Surgery (CRS)Also: CRSCytoreductive surgery | Procedure or surgery | CRS with adjuvant IV/IP chemotherapy, CRS/HIPEC with adjuvant IV chemotherapy |
| Adjuvant ChemotherapyAlso: Post-operative chemotherapy, Systemic chemotherapySix weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles | Drug | CRS with adjuvant IV/IP chemotherapy, CRS/HIPEC with adjuvant IV chemotherapy |
| QuestionnaireAlso: FACT-O QuestionnaireQuestionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants | Other | CRS with adjuvant IV/IP chemotherapy, CRS/HIPEC with adjuvant IV chemotherapy |
| Hyperthermic intraperitoneal chemotherapyAlso: HIPECHyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6 | Procedure or surgery | CRS/HIPEC with adjuvant IV chemotherapy |
| CarboplatinAlso: ParaplatinAUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles. | Drug | CRS/HIPEC with adjuvant IV chemotherapy |
| PaclitaxelAlso: Taxol175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles | Drug | CRS/HIPEC with adjuvant IV chemotherapy |
| PaclitaxelAlso: TaxolDay 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles | Drug | CRS with adjuvant IV/IP chemotherapy |
| CisplatinAlso: CDDPDay 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles | Drug | CRS with adjuvant IV/IP chemotherapy |
Primary outcome
Post-operative complication rates
Time frame: 30 days post-operative
Compare post-operative complication rates between study arms
3 secondary outcomes
Assessment of quality of life
Time frame: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Evaluate the rate of progression free survival
Time frame: at 24 months
Evaluate overall survival
Time frame: at 1, 3, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Related trials for Stage III Ovarian Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 3
Clinical Trials Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer
Ovarian Cancer
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.
Teresa Diaz-Montes, M.D. principal investigator
Mercy Medical Center
Armando Sardi, M.D. principal investigator
Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytoreductive Surgery (CRS), Adjuvant Chemotherapy and Questionnaire in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by Mercy Medical Center at 1 site in United States.
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 21 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Post-operative complication rates (time frame: 30 days post-operative). 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 19 Nov 2024.