A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

Ovarian Cancer Clinical Trial

Official title:

A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04473339
• Other study ID #: 2020107
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2020
• Source: Zhongnan Hospital
• Contact: Hongbing Cai, Doctor
• Phone: +86-27-67812648
• Email: chb2105[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75

• Karnofsky performance status >50 or World Health Organization performance score < 2

• primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)

• preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)

• lesion can be removed completely or residual disease < 0.5 cm

• last chemotherapy finished no more than 12 weeks after surgery

• no hepatic function damage

• white blood cell count =3.5*10^9/L; platelet count =80*10^9/L; Hemoglobin =90g/L

• no contraindication of surgery and anesthesia

• life expectancy = 3 months

• informed consent form signed

Exclusion Criteria:

• age < 18 or >75

• no history of other cancer

• platinum allergy

• distant metastasis

• used anti-angiogenic drug within 8 weeks

• possibility of more than two resection of alimentary canal

• recurrence < 6 months after primary treatment

• histologic type: non epithelial origin

• infection out of control

• follow-up unable to carry on (geographic or psychic)

• cardiac insufficiency or respiratory insufficiency

• has received HIPEC already

• being in other clinical study

• pregnancy or lactation period

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fever
• Homologous Recombination Repair Gene Mutation
• Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
• Ovarian Cancer
• Ovarian Cancer, Epithelial
• Ovarian Neoplasms

Intervention

Procedure:
• CRS+HIPEC
Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.
• CRS alone
Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
CAI Hongbing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.	up to 36 months since diagnosis
Secondary	Overall Survival	The overall survival interval was the time between diagnosis and death or last follow-up.	up to 36 months since histological diagnosis
Secondary	DP9	The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.	the 1 day of histological diagnosis and 9 months after
Secondary	DP12	The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.	the 1 day of histological diagnosis and 12 months after
Secondary	Serious adverse events, SAEs	Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0	surgery and with in 30 days