None listed
Conditions
Brief summary
This study is investigating the safety of administering heated (42 degrees Celsius) versus normal temperature (37 degrees Celsius) chemotherapy during surgery for ovarian cancer patients. Who is it for? You may be eligible for this trial if you are a female aged 18-75 years who has been diagnosed with primary stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. You must have had 3-4 cycles of pre-operative platinum-based chemotherapy and be fit for surgery. Study details Participants will receive cisplatin chemotherapy administered intraperitoneally to the abdominal cavity during surgery. They will randomly be allocated to either a hyperthermic arm, who will receive the chemotherapy drug heated to 42 degrees Celsius, or a normothermic arm who will receive the drug at normal body temperature of 37 degrees Celsius. Follow-up information about adverse events, quality of life and disease outcomes will be collected following the surgery. Information from this study will be used to design future trials evaluating the efficacy of heated chemotherapy.
Interventions
Participants in the experimental arm of normothermic intraperitoneal chemotherapy (NIPEC) will receive 100 mg/m² of cisplatin, heated to 37°C (normal body temperature), through a catheter into the abdominal cavity for 90 minutes during surgery
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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. This includes retroperitoneal lymph nodes involement, superficial/subcapsular liver lesions, and selected stage IV disease such as splenic disease, abdominal wall disease and full thickness bowel wall involvement if this can be resected with clear margins. 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 8. Surgery should be performed at least 21 days after cycle 3 or 4 day 1 (C3D22 or C4D22) but before day 42 (C3D42 or C4D42). 9. Adequate bone marrow function. 10. Adequate liver function 11. Adequate renal function as defined by creatinine clearance >50 ml/min as per Cockcroft-Gault formula. 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 within 6 weeks of CRS. 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.
Outcome results
None listed