Table 4. Ongoing randomized controlled trials about CRS and HIPEC for primary and recurrent EOC found in clinicalregister.gov at March 2020.
| Clinical trial number | Title of trial | Type of tumor | Trial design | Country | Primary/Recurrence | State of trial |
|---|---|---|---|---|---|---|
| NCT02681432 | Hyperthermic Intraperitoneal Chemotherapy with Paclitaxel in Advanced Ovarian Cancer (HIPECOVA) | EOC | HIPEC-arm: CRS+HIPEC with paclitaxel (175 mg /m2) for 60 minutes at a 42−43° degrees; followed by adjuvant systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles | Spain | P | Recruiting |
| Control arm: CRS followed by adjuvant systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles | ||||||
| NCT03842982 | Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) | EOC | Experimental: Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS) + Neo or Adjuvant chemotherapy (standard care) + HIPEC | France | P | Recruiting |
| Control arm: Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy ONLY (standard care, without HIPEC) | ||||||
| NCT03373058 | Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery (EHTASEOCCS) |
EOC, FTC, PPC | Experimental arm: CRS+HIPEC with Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 intraperitoneally in succession, followed by 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour (Docetaxel 75 mg/m2, if paclitaxel is not available) + carboplatin AUC = 5-6 IV>1 hour, every 3 weeks | China | P | Recruiting |
| Control arm: CRS followed by 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour (Docetaxel 75 mg/m2, if paclitaxel is not available) + carboplatin AUC = 5-6 IV>1 hour, every 3 weeks | ||||||
| NCT03275194 | HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy | EOC | After CRS patients will be randomized | Mexico | P | Recruiting |
| Experimental arm: HIPEC procedure with cisplatin and doxorubicin | ||||||
| Control arm: not additional treatment | ||||||
| NCT02124421 | HOT: HIPEC in Ovarian Cancer as Initial Treatment | EOC, FTC, PPC | Experimental arm: CRS/HIPEC using carboplatin for 90 minutes with adjuvant IV chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles | USA | P | Recruiting |
| Control arm: CRS alone with adjuvant IV chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175 mg/m2) will be given every 21 days for a total of 6 cycles | ||||||
| NCT03188432 | Hyperthermic Intraperitoneal Chemotherapy or Intraperitoneal Chemotherapy in Comparing Quality of Life in Patients with Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | EOC, FTC, PPC | Experimental: Arm I (paclitaxel, carboplatin, CRS, IP chemotherapy) Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 3 courses of chemotherapy, patients undergo CRS. Beginning 4-8 weeks after CRS, patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IP over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity | USA | P | Recruiting |
| Experimental: Arm II (paclitaxel, carboplatin, CRS, HIPEC) | ||||||
| Control arm: Patients receive paclitaxel IV over 90 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 6 courses of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 120 minutes immediately following CRS | ||||||
| NCT01628380 | Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer (CHORINE) | EOC | Experimental arm: neoadjuvant chemotherapy followed by CRS + HIPEC with CDDP + Paclitaxel | Italy | P | Unknown |
| Control arm: neoadjuvant chemotherapy followed by CRS alone | ||||||
| NCT02328716 | Cytoreduction with or without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients with Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma | EOC, FTC, PPC | Procedure: Cytoreduction | Spain | P | Unknown |
| Drug: HIPEC with cisplatin | ||||||
| NCT01091636 | Intraoperative Hyperthermic Intraperitoneal Chemotherapy with Ovarian Cancer | EOC | Experimental arm: HIPEC in Patients with ovarian cancer followed by adjuvant chemotherapy | Korea | P | Unknown |
| NCT03772028 | Primary Cytoreductive Surgery with or without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2) | EOC | Experimental arm: Primary CRS+HIPEC with cisplatin | Netherlands | P | Not yet recruiting |
| Control arm: Primary CRS | ||||||
| NCT03180177 | Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer | EOC, FTC, PPC | Experimental arm: HIPEC with paclitaxel 175 mg/m2and cisplatin 75 mg/m2 intraperitoneally in succession, 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour+ carboplatin AUC =5-6 IV>1 hour, every 3 weeks; Interval debulking surgery + HIPEC with paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 intraperitoneally in succession, followed by 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour+ carboplatin AUC =5-6 IV>1 hour, every 3 weeks |
China | P | Not yet recruiting |
| Control arm: 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour+ carboplatin AUC =5-6 IV>1 hour, every 3 weeks; Interval debulking surgery followed by 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m2 IV>3 hour+ carboplatin AUC =5-6 IV>1 hour, every 3 weeks | ||||||
| NCT01376752 | Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment (CHIPOR) |
EOC | Experimental arm: CRS+HIPEC with 75 mg/m2 of cisplatin | France | R | Recruiting |
| Control arm: CRS | ||||||
| NCT00426257 | Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer (OVHIPEC) | EOC | Experimental arm: Secondary CRS+HIPEC | Netherlands | R | Completed |
| Control arm: Secondary CRS | ||||||
| NCT01539785 | Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence (HORSE) | EOC | Experimental arm: CRS followed by HIPEC in patients with platinum-sensitive first recurrence of ovarian cancer | Italy | R | Unknown |
| Contol arm: vCRS alone | ||||||
| NCT03220932 | Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer (HIPOVA-01) | EOC | All patients will start with three cycles of CT-BEV 15 mg/kg, and will then be randomly | France | R | Not yet recruiting |
| Experimental arm: Then one cycle of monochemotherapy without bevacizumab is administered and followed by an interval CRS+HIPEC with adjuvant chemotherapy and bevacizumab (CT-BEV - 15 mg/kg once every 3 weeks) until disease progression | ||||||
| Control arm: Chemotherapy and bevacizumab (CT-BEV) once every 3 weeks from enrollment until disease progression | ||||||
| NCT03371693 | Cytoreductive Surgery (CRS) Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer (HIPECOV) | EOC | Experimental arm: CRS+HIPEC and platinum-based intravenous chemotherapy | China | R | Active, not recruiting |
| A single drug lobaplatin (30 mg/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 | ||||||
| Control arm: Only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS | ||||||
| NCT01767675 | Outcomes After Secondary Cytoreductive Surgery with or without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | EOC, FTC, PPC | Experimental arm: Secondary CRS+HIPEC with carboplatin followed by systemic combination chemotherapy 5 cycles for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B). In some patients randomized to HIPEC at MSKCC only, peritoneal fluid and blood samples will be drawn before, during and after the HIPEC procedure | USA (MSKCC) | R | Active, not recruiting |
| Control arm: Secondary CRS alone followed by systemic combination chemotherapy 6 cycles |
Eoc, epithelial ovarian cancer; P, primary; R, recurrence; CRS, cytoreductive surgery; HIPEC, hyperthermic intraperitoneal chemotherapy; FTC, Fallopian tube cancer; PPC, primary peritoneal carcinoma; IVCT, intravenous chemotherapy; underline cells, recruiting.