Clinical trial NCT06484491: IMPT Dose Escalation for NSCLC (HyDose)
Official title: Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Neoplasms
Proton Therapy
Radiotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2024-07-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled trial, the aim is to test the hypothesis that proton therapy dose escalation using a heterogeneous simultaneous boost on the primary tumor as part of chemoradiotherapy for locally advanced non-small-cell lung cancer is safe, i.e. does not result in an increase in severe toxicity compared to standard-dose proton therapy. Secondarily, the goal is to estimate the treatment effect size, if any.

In the intervention group, patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 74.0 Gy or 64.0 Gy (RBE of 1.1) in 25 fractions, depending on proximity to the mediastinal envelope. In the control group, patients will receive 60.0 Gy intensity-modulated proton therapy in 25 fractions.


Eligibility criteria: Inclusion Criteria:

* Histologically proven stage III NSCLC
* Planned for CCRT and adjuvant immunotherapy (intention to treat)
* Primary tumour volume outside of mediastinal PRV (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation

Exclusion Criteria:

* Chemotherapy not given concurrently with radiotherapy
* Upfront decision that adjuvant immunotherapy is not possible
* Primary tumour overlapping ≥40% with mediastinal PRV

Primary outcomes:
measure: Severe (grade 3+) adverse effects in the first year after radiotherapy
timeFrame: Data for assesing safety will be recorded from day 1 to 365
Secondary outcomes:
measure: Local control of the lung tumour assessed by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: Data for assessing local control will be recorded up to 2 years after chemoradiotherapy
measure: Progression-free survival based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: Data for assessing progression-free survival will be recorded up to 2 years after chemoradiotherapy
measure: Distant metastasis control based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: Data for assessing distant metastasis will be recorded up to 2 years after chemoradiotherapy
measure: Overall survival
timeFrame: Data for assessing overall survival will be recorded up to 2 years after chemoradiotherapy
measure: Grade 2+ adverse effects (i.e., requiring medication), both acute and late
timeFrame: Data for assesing safety will be recorded from day 1 to 365
measure: Qualifying for adjuvant immunotherapy after finishing chemoradiotherapy yes/no
timeFrame: Data on qualifying for adjuvant immunotherapy will be recorded up to 6 weeks after finishing chemoradiotherapy
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30)
timeFrame: Data for assesing quality of life will be recorded up to day 730
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13-item (EORTC-QLQ-LC13)
timeFrame: Data for assesing quality of life will be recorded up to day 730
measure: 3 EuroQoL-5D three-level version (EQ-5D-3L)
timeFrame: Data for assesing quality of life will be recorded up to day 730
measure: Lymphocyte counts after finishing chemoradiotherapy
timeFrame: Data for assessing lymphocyte counts will be assessed between 4 and 6 weeks after chemoradiotherapy
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: UMCG
name: R. Wijsman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCG
name: A. Van der Wekken, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCG
name: E. Korevaar, dr ir (PhD)
role: PRINCIPAL_INVESTIGATOR
References: