IMPT Dose Escalation for NSCLC (HyDose)

Sponsor
University Medical Center Groningen
Study ID
NCT06484491
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dose-escalated intensity-modulated proton therapy (IMPT-74) — RADIATION
    Heterogeneous simultaneous integrated boost of 74.0 Gy (RBE) to primary tumor \>15mm away form mediastinal envelope, and 64.0 Gy (RBE) to primary tumor =\< 15mm away from mediastinal envelope. The rest of the clinical target volume, including affected lymph nodes, receives 60.0 Gy (RBE).
  • Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy — DRUG
    Induction course: -Cisplatin (75 mg/m2) or carboplatin (AUC 6) + pemetrexed (500mg/m2). Concurrent chemoradiotherapy: * Weekly cisplatin (20mg/m2) + docetaxel (20mg/m2) on Mondays. * Radiotherapy will be given for 5x5 days.
  • Immunotherapy: adjuvant durvalumab — DRUG
    Adjuvant treatment will be given starting 1-6 weeks after chemoradiotherapy if no progression, good performance (PS 0-1), no other contra-indication for immunotherapy. Doses: * Start durvalumab 10 mg/kg 1x/14 days. * If possible after 2 courses switch to 1500 mg flat dose 1x/4 wk. * Continue for 12 months in total.

Study Details

The goal of this clinical pilot trial is to learn if dose to the tumor in the lung can be safely increased using proton therapy in stage III non-small-cell lung cancer patients receiving combined chemotherapy and radiotherapy. The main questions it aims to answer are: * Is the risk of severe radiotherapy toxicities (requiring hospital admission) within acceptable margins ? * What is a rough estimate of the effect of the treatment under study? Compared to standard care in our clinic, all participants in this pilot trial will * Receive a higher dose of proton therapy to the tumor in the lung albeit with the same number of radiotherapy visits as the current standard treatment. * Receive two additional follow-up visits at the clinic after treatment, namely 4 and 6 weeks after finishing radiotherapy. * Two additional blood withdrawals at the last week of radiotherapy and 4 weeks after finishing radiotherapy, to measure a type of white blood cells. * Receive an extra quality of life questionnaire at the last week of radiotherapy.

Key Dates

Start date
Sep 1, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
87 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Intervention group
    Dose-escalated IMPT

Primary Outcome Measure

Severe (grade 3+) adverse effects up to six months after radiotherapy [ Time Frame: Data for assesing safety will be recorded from day 1 to 365 ]

Central Contacts

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