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Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy

30. Oktober 2026 aktualisiert von: QI WEIXIANG，MD, Ruijin Hospital

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

44

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Provision of written informed consent before any study-specific procedure.
  2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  3. Locally advanced (stage IIIA-IIIC) or oligometastatic NSCLC for which thoracic moderately hypofractionated radiotherapy is planned.
  4. 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.
  5. Age ≥18 years and ≤ 85 years.
  6. Expected survival >6 months.
  7. 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:

  1. Extensive distant metastasis (non-oligometastatic disease, defined as >5 metastatic lesions or >2 involved organs).
  2. Prior thoracic radiotherapy.
  3. Pregnancy or breastfeeding.
  4. Severe uncontrolled non-neoplastic medical comorbidity (e.g., severe cardiac, hepatic, or renal insufficiency).
  5. History of acute exacerbation of ILD within the past 3 months (confirmed by a respiratory medicine physician).
  6. Active infection or fever.
  7. 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.
  8. Any other condition that, in the investigator's opinion, makes the participant unsuitable for study enrollment.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Strahlung: Proton radiotherapy

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1-Year Overall Survival (OS) Rate
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of grade ≥3 acute radiotherapy-related adverse events
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ruijin Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. November 2026

Primärer Abschluss (Geschätzt)

30. Juni 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

25. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Oktober 2026

Zuerst gepostet (Tatsächlich)

5. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-829

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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