Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18 - 75
Clinical summary
Summary
Eligible participants will receive cisplatin chemotherapy administered to the abdominal cavity through a catheter for 90 minutes during surgery. Participants will be randomly allocated to either the hyperthermic arm, who will receive the chemotherapy drug heated to 42 degrees Celsius, or the normothermic arm, who will receive the drug at normal body temperature of 37 degrees Celsius.
Conditions
This trial is treating patients with stage 3 epithelial ovarian, fallopian tube and primary peritoneal cancer
Eligibility
Inclusion
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
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.
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
University of Sydney,Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Scientific Title
The safety of hyperthermic and normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial ovarian, fallopian tube and primary peritoneal cancer (HYNOVA).
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