A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme.
According to standard treatment.
NKI-AVL
Amsterdam, Netherlands
RECRUITINGLUMC
Leiden, Netherlands
RECRUITINGLoco-regional control after 24 months per completed treatment including salvage treatment
Proportion of patients free from local-regional progression
Time frame: 24 months after completed treatment
Disease-related treatment failure
Patients without an event will be censored at their last date of contact. The Kaplan-Meier method will be used to estimate freedom from disease-related failure. Difference between the two main treatment arms, NACT vs. chemotherapy, will be tested using a log-rank test. Incidences of disease-related failure will be reported based on the Kaplan-Meier estimates, together with confidence intervals for the hazard ratio using both 90 and 95% confidence levels.
Time frame: 24 months after completed treatment
Disease free survival
Time frame: 24 months after completed treatment
Patterns of recurrence of disease
Type of recurrence after treatment: local, regional or distant recurrence
Time frame: 24 months after completed treatment
Overall survival
Time frame: 24 months after completed treatment
Treatment related death
Time frame: 24 months after completed treatment
Prevention of trimodal treatment
Proportion of patients that don't need adjuvant surgery (arm 1) and number of patients that don't need adjuvant radiotherapy (arm 2)
Time frame: 24 months after completed treatment
Functional organ preservation
Proportion of patients for who an organ-sparing surgery is possible
Time frame: 24 months after completed treatment
Short term and long term complications
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 24 months after completed treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.