Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
NCT07919691, Phase 2, Not yet recruiting, Ruijin Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy | ClinicalTrials.gov |
| NCT number | NCT07919691 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 44 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ruijin Hospital | ClinicalTrials.gov |
| Conditions | Non-Small Cell Lung Cancer | ClinicalTrials.gov |
| Interventions | Proton radiotherapy | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 1-Year Overall Survival (OS) Rate | 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. | ClinicalTrials.gov |
| Secondary | Progression-free survival (PFS) | From start of radiotherapy up to 2 years | Time from start of radiotherapy to disease progression or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Local control (LC) | From start of radiotherapy up to 2 years | Time from start of radiotherapy to imaging-documented progression within the target volume (GTV/CTV). | ClinicalTrials.gov |
| Secondary | Incidence of grade ≥2 radiation pneumonitis | 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. | ClinicalTrials.gov |
| Secondary | Change in pulmonary function | 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. | ClinicalTrials.gov |
| Secondary | Incidence of grade ≥3 lymphopenia | During radiotherapy and up to 3 months after completion of radiotherapy | Proportion of participants with grade ≥3 lymphopenia according to CTCAE v5.0. | ClinicalTrials.gov |
| Secondary | Incidence of grade ≥3 hematologic toxicity | 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. | ClinicalTrials.gov |
| Other | Incidence of grade ≥3 acute radiotherapy-related adverse events | Within 3 months after completion of radiotherapy | Proportion of participants with any grade ≥3 acute radiotherapy-related adverse event according to CTCAE v5.0. | ClinicalTrials.gov |
| Other | Quality of life - European Organisation for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)