Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
A Prospective Clinical Study of Proton Moderately Hypofractionated Radiotherapy for Non-Small Cell Lung Cancer Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
The goal of this clinical trial is to learn if proton moderately hypofractionated radiotherapy works to treat non-small cell lung cancer in adults who cannot tolerate standard concurrent chemoradiotherapy. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does proton moderately hypofractionated radiotherapy improve the 1-year overall survival rate compared with historical data from similar patients? What medical problems do participants have during and after this treatment? This is a single-arm study, so all participants will receive proton radiotherapy. Researchers will compare results with historical control data, not with a placebo group. Participants will: Receive proton radiotherapy once daily for about 3 to 4 weeks.
Have checkups and tests before treatment, weekly during treatment, and regularly after treatment. Complete follow-up visits for at least 2 years, including imaging, blood tests, lung function tests, and quality-of-life questionnaires.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Weixiang Qi, Dr.
- Telefonní číslo: +86-021-64370045
- E-mail: qiweixiang1113@163.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Provision of written informed consent before any study-specific procedure.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Locally advanced (stage IIIA-IIIC) or oligometastatic NSCLC for which thoracic moderately hypofractionated radiotherapy is planned.
- Meets at least one of the following criteria defining inability to tolerate standard concurrent chemoradiotherapy: Frailty/older age: age ≥70 years AND Charlson Comorbidity Index (CCI) ≥1; OR Moderate or worse pulmonary function impairment: GOLD moderate or worse ventilatory impairment (FEV1/FVC <0.70 AND FEV1 ≤80% predicted) OR DLCO ≤60% predicted; OR Interstitial lung disease/pulmonary fibrosis confirmed by high-resolution chest CT or pathology, including idiopathic pulmonary fibrosis (IPF), nonspecific interstitial pneumonia (NSIP), connective tissue disease-associated ILD (CTD-ILD), and other ILD types, AND clinically stable with no evidence of acute exacerbation within the past 3 months.
- Age ≥18 years and ≤ 85 years.
- Expected survival >6 months.
- Assessed by a multidisciplinary team (including radiation oncology, respiratory medicine, and radiology) as having an indication for radiotherapy and being able to tolerate proton therapy.
Exclusion Criteria:
- Extensive distant metastasis (non-oligometastatic disease, defined as >5 metastatic lesions or >2 involved organs).
- Prior thoracic radiotherapy.
- Pregnancy or breastfeeding.
- Severe uncontrolled non-neoplastic medical comorbidity (e.g., severe cardiac, hepatic, or renal insufficiency).
- History of acute exacerbation of ILD within the past 3 months (confirmed by a respiratory medicine physician).
- Active infection or fever.
- History of another malignancy within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or similar cured malignancies.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for study enrollment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Proton Moderately Hypofractionated Radiotherapy
All participants will receive thoracic proton moderately hypofractionated radiotherapy as a single-arm intervention. The standard regimen is 54 GyE in 18 fractions (3 GyE per fraction). For patients who cannot meet normal-tissue dose constraints or are at very high risk, prespecified de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions is permitted; doses below 48 GyE/16 fractions require study withdrawal. Treatment planning prioritizes target coverage (Clinical target volume, CTV V95 ≥95%, Gross tumor volume, GTV V100 ≥100%) while respecting standard organ-at-risk constraints, lymphocyte-sparing organ constraints, and additional esophageal sparing where feasible. Patients with interstitial lung disease receive stricter lung dose limits. No placebo or comparator intervention is administered; outcomes will be compared with historical control data. |
Thoracic intensity-modulated proton therapy (IMPT) delivered as moderately hypofractionated radiotherapy. The standard prescription is 54 GyE in 18 fractions (3 GyE per fraction), with protocol-defined de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions for patients who cannot meet normal-tissue constraints or are at very high risk; doses below 48 GyE/16 fractions are not permitted. This intervention is distinguished from standard photon concurrent chemoradiotherapy by the use of proton therapy, omission of concurrent chemotherapy, a shorter 3-4 week course, and prespecified planning priorities that include target coverage, standard organ-at-risk limits, lymphocyte-sparing organ constraints, and optional esophageal sparing. Patients with interstitial lung disease receive stricter lung dose constraints. IMPT plans are robustly optimized for 3.5% range uncertainty and 3 mm setup uncertainty. No placebo or comparator is |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
1-Year Overall Survival (OS) Rate
Časové okno: 1 year from the start of radiotherapy
|
Proportion of participants alive at 1 year after initiation of proton radiotherapy. Survival time is defined from the start of radiotherapy to death from any cause or last follow-up; participants lost to follow-up will be censored. |
1 year from the start of radiotherapy
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-free survival (PFS)
Časové okno: From start of radiotherapy up to 2 years
|
Time from start of radiotherapy to disease progression or death from any cause, whichever occurs first. |
From start of radiotherapy up to 2 years
|
|
Local control (LC)
Časové okno: From start of radiotherapy up to 2 years
|
Time from start of radiotherapy to imaging-documented progression within the target volume (GTV/CTV). |
From start of radiotherapy up to 2 years
|
|
Incidence of grade ≥2 radiation pneumonitis
Časové okno: Within 6 months after completion of radiotherapy
|
Proportion of participants with grade ≥2 radiation pneumonitis according to Common Terminology Criteria for Adverse Events Version (CTCAE) v5.0. |
Within 6 months after completion of radiotherapy
|
|
Change in pulmonary function
Časové okno: Baseline, and 3, 6, and 12 months after radiotherapy
|
Change in Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity(FVC), and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) from baseline to post-radiotherapy assessments. |
Baseline, and 3, 6, and 12 months after radiotherapy
|
|
Incidence of grade ≥3 lymphopenia
Časové okno: During radiotherapy and up to 3 months after completion of radiotherapy
|
Proportion of participants with grade ≥3 lymphopenia according to CTCAE v5.0. |
During radiotherapy and up to 3 months after completion of radiotherapy
|
|
Incidence of grade ≥3 hematologic toxicity
Časové okno: During radiotherapy and up to 3 months after completion of radiotherapy
|
Proportion of participants with grade ≥3 leukopenia, neutropenia, or thrombocytopenia according to CTCAE v5.0. |
During radiotherapy and up to 3 months after completion of radiotherapy
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of grade ≥3 acute radiotherapy-related adverse events
Časové okno: Within 3 months after completion of radiotherapy
|
Proportion of participants with any grade ≥3 acute radiotherapy-related adverse event according to CTCAE v5.0. |
Within 3 months after completion of radiotherapy
|
|
Quality of life - European Organisation for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30)
Časové okno: Baseline, end of radiotherapy (week 4), and 3, 6, and 12 months after radiotherapy.
|
Change in EORTC QLQ-C30 scores from baseline. The QLQ-C30 is a 30-item questionnaire with multi-item functional scales (physical, role, cognitive, emotional, social) and a global health status/QoL scale, scored from 0 to 100, where higher scores indicate better functioning or better quality of life; and symptom scales/items (fatigue, pain, nausea/vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial impact), scored from 0 to 100, where higher scores indicate greater symptom burden or worse status. |
Baseline, end of radiotherapy (week 4), and 3, 6, and 12 months after radiotherapy.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-829
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
This is a small, single-arm, investigator-initiated trial in a rare high-risk population; the informed consent and ethics approval cover only aggregate reporting, and the limited number of participants creates a meaningful risk of re-identification. Only de-identified aggregate results will be reported.
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