Epithelial Ovarian Cancer, Hyperthermic Intraperitoneal Chemotherapy(HIPEC), Ovarian Cancer, Ovarian Cancer, Epithelial, Ovarian Neoplasms, Ovary Neoplasm
Conditions
Keywords
hyperthermic intraperitoneal chemotherapy, epithelial ovarian cancer
Brief summary
A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.
Detailed description
This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.
Interventions
DEVICEHIPEC
Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.
DEVICECRS
cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.
DEVICEIVCT
platinum-based intravenous chemotherapy
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival rate | 5 years | assess overall survival rate in 5 years in both arms |
| 1 year survival rate | 1 year | assess the survival rate in 1 year for both arms |
| 3 year survival rate | 3 years | assess the survival rate in 3 years for both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 years | assess the Progression-free survival rate during 5 years for both study arms |
| quality of life | 5 years after CRS or until death | Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment. |
| postoperative complication | 5 years | measured with physical examination and/or computed tomography（CT）and/or ultrasound examination. |
Countries
China
Outcome results
None listed