Evaluating the effects of heated chemotherapy during a second look surgery for ovarian cancer
A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
This study is testing if a special heated chemotherapy treatment during a follow-up surgery can help improve the quality of life for women with ovarian or fallopian tube cancers who have no signs of disease after their first treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04415944 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility and impact on quality of life of administering hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin during a second look laparoscopy in patients with ovarian and fallopian tube cancers. The primary objective is to determine if this combined approach is practical and safe for patients who have shown no clinical evidence of disease after initial treatments. Secondary objectives include comparing the quality of life outcomes between patients receiving HIPEC and those undergoing standard cytoreductive surgery with systemic chemotherapy alone, as well as documenting any associated toxicities. Participants will be monitored for up to six months post-treatment to evaluate health effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed Stage I-III ovarian or fallopian tube cancer who have shown no clinical evidence of disease after prior treatments.
Not a fit: Patients with active disease or those who have not undergone prior cytoreductive surgery and platinum-based chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with ovarian and fallopian tube cancers.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy * Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery. * Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy * The intraoperative peritoneal adhesion index should be \< 10. * Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy. * Age ≥ 18 years. * ECOG performance status ≤ 2. * Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count \>1,500/mcL; platelets \>100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal * Adequate contraception and negative pregnancy test if pregnancy possible. * Ability to understand and the willingness to sign an IRB-approved informed consent document. Exclusion Criteria: * Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy * Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above. * Patients may not have received prior abdominal or pelvic radiation. * Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of \>10 as defined above * Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnancy Men are excluded from participation due to the site-specific nature of the disease being studied.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Laurel Berry, MD — Wake Forest University Health Sciences
- Study coordinator: Study Nurse
- Email: arcarrol@wakehealth.edu
- Phone: 336-713-3539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.