Clinical trials of radiotherapy and cell-signaling inhibitors and hypoxia sensitizers
| Identifier | Phase | N | Title | Disease | Interventions | Radiation details | Primary outcome | Secondary outcomes |
| Not yet recruiting | ||||||||
| NCT04169763 | I | 18 | Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery | Unresectable T2-4, N0-3 vulvar carcinoma | Nelfinavir twice daily for 8 weeks, cisplatin-based CRT weeks 2–8 | EBRT (5 days a week, weeks 2–8) | Recommended phase II dose of nelfinavir; incidence of AE | PFS; OS |
| NCT03086681 | III | 120 | A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy vs Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma | Locally advanced cervical cancer (FIGO 2009 Ib, IIa2, IIb–IVa) | Endostar (daily for days 1–10, repeated q15 days for four cycles) with CRT (cisplatin based); CRT (cisplatin based) | IMRT 45–50 Gy | Short-time effect (image assessment of cancer status) | OS; PFS |
| Recruiting | ||||||||
| NCT02363829 | I | 6 | A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II–IVA) | Locally advanced cervical cancer (FIGO stage II–IVA | Twice daily nelfinavir with CRT (cisplatin based) | Whole-pelvis EBRT and intracavitary brachytherapy | AE | |
| NCT02394652 | II | 48 | The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial | Locally advanced cervical cancer (FIGO stage IB2–IVA) | Metformin administration 1 week before CRT (cisplatin based); standard CRT (cisplatin) | EBRT | Change in fractional hypoxic volume of the tumor via FAZA-PET scan | DFS; acute and late GI and GU toxicities; effect on endogenous hypoxia and other markers; biomarkers of metformin response |
| NCT03622827 | II | 120 | Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS) | High-risk early stage cervical cancer | CRT with cisplatin and 5-flurouracil q3w for two cycles with Endostar (recombinant human endostatin) given 3 days before chemotherapy for both cycles | IMRT to 45–50 Gy in 6 weeks | 3 year DFS; AE | Time to distant metastasis survival; LRR; OS; HR-QoL |
| NCT03256916 | III | 300 | A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine Cervix | FIGO stage IIIB carcinoma cervix | Nelfinavir 5–7 days before CRT (cisplatin based); standard CRT (cisplatin) | Pelvic EBRT 46 Gy in 23 fractions | 3 year DFS | LRC; OS; AE incidence; change in Akt levels in the tumor; tumor hypoxia via PET/MRI; Cmax (variability of distribution); clearance of nelfinavir; half-life of nelfinavir |
AE, adverse events; CRT, chemo-radiation therapy; DFS, disease-free survival; EBRT, external-beam radiation therapy; FAZA-PET, 18F-fluoroazomycin arabinoside positron emission tomography; FIGO, International Federation of Obstetrics and Gynecology; GI, gastrointestinal; GU, genitourinary; HR-QoL, health-related quality of life; IMRT, intensity-modulated radiation therapy; LRC, local-regional control; LRR, local-regional recurrence; OS, overall survival; PFS, progression-free survival; qw3, once every 3 weeks.