Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer.

Phase 2

Recruiting

• Conditions: Ovarian cancer; Fallopian tube cancer; Primary peritoneal cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12621000269831
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-11
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Age 18 -75 years
2. Participants diagnosed with primary FIGO stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity.
3. Histopathology must be high grade serous, endometroid (grade 2 and 3), clear cell adenocarcinoma or mixed high grade histologies.
4. Have 3-4 cycles of pre-operative platinum-based chemotherapy
5. No progression of disease on radiological imaging and/or Ca125 during neoadjuvant chemotherapy
6. ECOG performance status 0 or 1
7. Fit for surgery as determined by study surgical team
9. Adequate bone marrow function.
10. Adequate liver function
11. Adequate renal function
12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
13. Signed, written informed consent.

Exclusion Criteria

1. Participants with extra-abdominal disease.
2. Participants with intrahepatic or other visceral metastasis detected on radiological imaging which is not surgically resectable at diagnosis and/or after pre-operative chemotherapy treatment.
3. Any contraindications to receiving intraperitoneal cisplatin chemotherapy as per the treating medical oncologist such as drug allergy.
4. Had received bevacizumab in combination with neo-adjuvant chemotherapy treatment
5. Serious medical or psychiatric conditions that may prevent compliance with the protocol or that may compromise assessment of key outcomes
6. History of another malignancy within 5 years prior to registration. Participants with curatively treated cervical carcinoma in situ or non-melanomatous carcinoma of the skin, or participants who have been free of other malignancies for greater than or equal to 5 years prior to registration are eligible for this study
7. Concurrent illness, including active intra-abdominal sepsis that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety as determined by the study surgical team.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing any adverse events greater than or equal to grade 3 (CTCAE v5.0 and Clavien-Dindo classification) e.g. nausea and vomiting.[Within 90 days post-surgery ]