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NCT06484491 | NOT YET RECRUITING | Carcinoma, Non-Small-Cell Lung

IMPT Dose Escalation for NSCLC (HyDose)
Sponsor:

University Medical Center Groningen

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.

Condition or disease

Carcinoma, Non-Small-Cell Lung

Intervention/treatment

Standard-dose intensity-modulated proton therapy (IMPT-60)

Dose-escalated intensity-modulated proton therapy (IMPT-74)

Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Immunotherapy: adjuvant durvalumab

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
IMPT Dose Escalation for NSCLC (HyDose)

Location Details

NCT06484491

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How to Participate

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Locations

Not yet recruiting

Netherlands,

UMCG

Groningen, Netherlands,