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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Weixiang Qi, Dr.
- Telefonnummer: +86-021-64370045
- E-post: qiweixiang1113@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1-Year Overall Survival (OS) Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of grade ≥3 acute radiotherapy-related adverse events
Tidsramme: 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)
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-829
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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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