Table 2.
Study protocols for phase III studies evaluating CRS and HIPEC with unpublished results.
| NCT Number | Patients | End Until | Location | Arm Intervention | Arm Control | Open/Closed | HIPEC Drug | HIPEC Solution/Duration | Temperature | Primary Outcome Measures | Secondary Outcome Measures |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03023436 | 220 | 22 June | China | CRS + HIPEC + sCTx | single arm | closed | DTX 120 mg | 5 L saline; 70 min | 43 ± 0.5 °C | MS 2-year (24 months) | 1. 2-year OS; 2. 2-year PFS; 3. M&M (30 d; 24 months) |
| NCT02158988 | 105 | 21 September | Germany | CRS + HIPEC + sCTx | CRS + sCTx | open/closed | MMC 15 mg/m2 CDDP 75 mg/m2 | 5 L saline; 60 min | 41–42 °C | OS (2.5 years) | 1. PFS; 2. M&M (30 d; 24 months) 3. MFS; 4. QoL (every 6 months) |
| NCT03348150 | 182 | 22 October | The Netherlands | CRS + HIPEC + sCTx | palliative sCTx | open | OX 460 mg/m2 DTX 50 mg/m2 | ns; 30 + 90 min | 41–42 °C + 37 °C | OS (5 years) | 1. PFS 2. toxicity 3.cost and health benefits |
MMC: mitomycin C; CDDP: cisplatin; MS: median survival; OS: overall survival; PFS: progression-free survival; QoL: quality of life; DTX: docetaxel; OX: oxaliplatin; sCTx: systemic chemotherapy; M&M: morbidity and mortality.