InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 2 February 2024

HyNOVA: This phase II study is investigating how safe and effective it is to administer heated (42 degrees Celsius) versus normal temperature (37 degrees Celsius) chemotherapy during surgery for people with epithelial ovarian, fallopian tube or peritoneal cancerThe safety of hyperthermic and normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial ovarian, fallopian tube and primary peritoneal cancer (HYNOVA).

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.

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18 - 75

Phase

II

Trial Acronym

HyNOVA

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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).

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.