Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT).
Warren R BacorroKathleen BaldiviaMark DumagoMaureen BojadorAbigail MiloCelestine Marie TrinidadJocelyn MarianoGil GonzalezTeresa Sy OrtinPublished in: Acta oncologica (Stockholm, Sweden) (2022)
For the phase 1, the primary endpoint is dose-limiting toxicity (DLT), or any grade ?3 acute or sub-acute toxicity. The dose level at which incidence of DLT is ?33% is defined as the maximum tolerance dose (MTD). For the phase 2, the primary endpoint is complete response at 3 months post-treatment. Secondary outcomes are progression-free and overall survival, acute and late toxicity, and patient-reported outcomes (EPIC, EORTCQLQ C30 + CX24, PGIC, PCIS). Trial registration: NCT05210270.
Keyphrases
- liver failure
- patient reported outcomes
- respiratory failure
- oxidative stress
- aortic dissection
- radiation therapy
- drug induced
- clinical trial
- early stage
- locally advanced
- randomized controlled trial
- small cell lung cancer
- squamous cell carcinoma
- risk factors
- type diabetes
- intensive care unit
- extracorporeal membrane oxygenation
- skeletal muscle
- acute respiratory distress syndrome
- free survival
- open label
- mechanical ventilation
- replacement therapy