Clinical trial · Interventional
Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This research study is looking at an alternative way of delivering radiation therapy with protons. Protons are tiny particles with a positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Information from other research studies suggests that proton radiation may help to reduce unwanted side effects from radiation and allow an increase in radiation dose that increase the odds of tumor killing. The purpose of this study is to determine the safest dose of proton radiation therapy to give in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation, Chemotherapy and Surgery
- description
- Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
- interventionNames
- Radiation: Proton Beam Radiation
- Drug: Cisplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- MTD
- timeFrame
- 1.5 years
- description
- To establish the MTD of a proton beam-based regimen consisting of 25 fractions, together with concurrent standard cisplatin and etoposide chemotherapy followed by surgery +/- adjuvant chemotherapy for Stage III NSCLC, and to describe post-treatment surgical complications and treatment toxicity using CTCAE v4.0
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer with a clinical stage of IIIA * Candidate for chemoradiation and surgical resection * Measurable disease * Life expectancy \> 6 months * Normal organ and marrow function Exclusion Criteria: * Pregnant or breast-feeding * Prior therapy for lung cancer with chemotherapy * Prior chest radiation * Compromised pulmonary function * Severe neurovascular disease * History of high cardiac risk including unstable angina * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, clinically significant or serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * History of a different malignancy unless disease-free for at least 3 years and at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, non muscle-invasive bladder cancer, basal cell or squamous cell carcinoma of the skin * Subjects with HIV
References
Publications (0)
Data not yet available