Table 3

Clinical trials of radiotherapy and cell-signaling inhibitors and hypoxia sensitizers

IdentifierPhaseNTitleDiseaseInterventionsRadiation detailsPrimary outcomeSecondary outcomes
Not yet recruiting
NCT04169763I18Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by SurgeryUnresectable T2-4, N0-3 vulvar carcinoma Nelfinavir twice daily for 8 weeks, cisplatin-based CRT weeks 2–8EBRT (5 days a week, weeks 2–8)Recommended phase II dose of nelfinavir; incidence of AEPFS; OS
NCT03086681III120A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy vs Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical CarcinomaLocally 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 GyShort-time effect (image assessment of cancer status)OS; PFS
NCT02363829I6A 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–IVATwice daily nelfinavir with CRT (cisplatin based)Whole-pelvis EBRT and intracavitary brachytherapyAE
NCT02394652II48The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized TrialLocally advanced cervical cancer (FIGO stage IB2–IVA) Metformin administration 1 week before CRT (cisplatin based); standard CRT (cisplatin)EBRTChange in fractional hypoxic volume of the tumor via FAZA-PET scanDFS; acute and late GI and GU toxicities; effect on endogenous hypoxia and other markers; biomarkers of metformin response
NCT03622827II120Postoperative 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 cancerCRT with cisplatin and 5-flurouracil q3w for two cycles with Endostar (recombinant human endostatin) given 3 days before chemotherapy for both cyclesIMRT to 45–50 Gy in 6 weeks3 year DFS; AETime to distant metastasis survival; LRR; OS; HR-QoL
NCT03256916III300A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine CervixFIGO stage IIIB carcinoma cervix Nelfinavir 5–7 days before CRT (cisplatin based); standard CRT (cisplatin)Pelvic EBRT 46 Gy in 23 fractions3 year DFSLRC; 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.