Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Conditions

• Stage III Fallopian Tube Cancer
• Stage III Ovarian Cancer
• Stage III Primary Peritoneal Cancer
• Stage IV Fallopian Tube Cancer
• Stage IV Ovarian Cancer
• Stage IV Primary Peritoneal Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cisplatin — DRUG
  Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius
• No treatment — OTHER
  No treatment with Cisplatin

Study Details

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

Key Dates

Start date

Mar 8, 2024

Status verified

Dec 2025

Primary completion

Aug 1, 2029

Completion

Aug 1, 2034

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: HIPEC
  Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cisplatin 100 mg/m2 IP over 90 minutes at 42 degrees C
• Active Comparator: No HIPEC
  No treatment

Primary Outcome Measure

Progression-free survival [ Time Frame: From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years ]

Central Contacts

• Sarin Chhab
  215-854-0770
  [email protected]
• Shanon Matkin
  801-661-1584
  [email protected]

Locations (59)

Find similar trials in Duarte, CA

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