Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)

Ovarian Cancer Clinical Trial

Official title:

Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827523
• Other study ID #: NCC2023-0100
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2023
• Source: National Cancer Center, Korea
• Contact: Myong Cheol Lim, MD, Ph.D
• Phone: +820319201760
• Email: gynlim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Description:

The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III-IV primary epithelial ovarian cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Signed and written informed consent,

2. Patients =18, <80 years old,

3. Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy,

4. Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,

5. A life expectancy > 3 months as clinically judged,

6. Adequate organ function for cytoreductive surgery and HIPEC,

7. Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,

8. Patients can also consent to the provision of clinical information for secondary use, such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information.

Exclusion Criteria:

1. Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor

2. Patients who have not undergone neoadjuvant chemotherapy,

3. Interval cytoreduction with more than 2.5 mm depth of residual disease,

4. A life expectancy =3 months as clinically judged,

5. History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2,

6. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,

7. Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology,

8. Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics),

9. Active tuberculosis that is not controlled within 1 month of treatment,

10. Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,

11. Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin),

12. Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or,

13. History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Cisplatin
Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		From randomization to the date of death from any cause, assessed up to 5 years
Secondary	Progression-free survival (PFS)		From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Secondary	Cancer-specific survival		From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Secondary	Time to first subsequent therapy (TFST)	the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy	from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, assessed up to 5 years
Secondary	Treatment-related adverse events	assessed by CTCAE ver.5.0	From randomization up to the end of treatment plus 4 weeks
Secondary	Health-related quality of life (EORTC-QLQ-C30)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.	Over the 5 year surveillance period
Secondary	Health-related quality of life (EORTC-QLQ-OV28)	The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.	Over the 5 year surveillance period
Secondary	Health-related quality of life (EQ-5D-5L)	Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).	Over the 5 year surveillance period
Secondary	Cost-effectiveness analysis	assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)	At time of completion of 5-year surveillance period