Studies
RAPID – Favourable-risk Cervical Cancer
Overview
Rationale: Current standard treatment for locally advanced cervical cancer including chemoradiotherapy and image-guided adaptive radiotherapy has shown excellent disease control across all stages. In particular, specific disease characteristics were identified in precursor studies for patients at lower risk of recurrence. As treatment-related morbidity is still present, albeit mainly in mild or moderate form, there is yet an opportunity to further adapt and individualise radiation dose in treatment for patients with favourable risk characteristics in order to decrease the morbidity rate while maintaining the same disease control. Study design: Single arm phase-II study. Study population: Locally advanced cervical cancer patients with FIGO2018 stage IB1, IB2, IB3, IIA or IIB. All lymph node negative (N0) Age ≥18 years old Favourable risk features of tumour width ≤ 5 cm No mid or upper uterine involvement No distal parametrial invasion No adenocarcinoma or adeno-squamous histology No necrosis on MRI. Intervention: Radiation dose will be adapted according to risk of recurrence. This implies that: 1) prescribed EBRT dose is 40Gy in 20 fractions, and 2) the cumulative EBRT+BT dose is adapted according to tumor response during EBRT. Main study parameters/endpoints: Primary endpoint is pelvic control at 2 and 5 years. Secondary endpoints are local, pelvic nodal, para-aortic nodal, systemic, and overall disease control (2 and 5 years), disease free survival and overall survival (2 and 5 years), physician-assessed gastrointestinal, urinary, vaginal and non-organ related morbidity (4 weeks after start of treatment, end of treatment, 2 and 5 years), patient-reported symptoms and Quality of Life.
Objectives
- Adapt radiation dose according to risk for external beam radiotherapy (EBRT) and brachytherapy (BT) to decrease treatment-related morbidity compared to standard of care while maintaining the same pelvic disease control.