Clinical trial · Interventional
Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
A Bayesian Randomized Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Photon Therapy | Radiation | — | UNRESOLVED |
| Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Group 1: Photon Therapy - 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.
- interventionNames
- Radiation: Photon Therapy
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Group 2: Proton Therapy - 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.
- interventionNames
- Radiation: Proton Therapy
- Drug: Paclitaxel
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically proven, unresected, locoregionally advanced NSCLC without evidence of hematogenous metastases (stage II-IIIB disease according to the 7th edition of the AJCC Staging Manual) with exception as defined by inclusion #2). 2. Patients with solitary brain metastasis without sign of progression in the brain at the time of registration will be eligible for this trial if there is clinical indication for concurrent chemoradiation to the primary disease in the lung. 3. Suitability for concurrent chemoradiation therapy per treating radiation oncologists or treating medical oncologist's: A) Karnofsky performance score of \>/= 70, or ECOG 0-1 B) Unintentional weight loss \</= 10% during the 3 months before study entry. 4. Receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed for this protocol. 5. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan. 6. Locoregional recurrence after surgical resection, if suitable for definitive concurrent chemoradiation is allowed for this protocol. 7. Forced expiratory volume in the first second (FEV1) \>/= 1 liters. 8. Fluorodeoxyglucose (FDG) -PET scan within 3 months before registration. The pretreatment (diagnostic) PET/CT should, whenever possible, be performed together with the 4-D CT simulation. PET images acquired either at the time of simulation or acquired separately should be registered with the planning CT to assist in tumor delineation. 9. Standard pretreatment evaluations (as decided by treating radiation oncologist, medical oncologist, surgeons or pulmonologist), to include MRI or CT scan of the brain, contrast CT scan of the thorax and upper abdomen, Whole-body PET/CT, pulmonary function tests, lung and cardiac single proton emission computed tomography (SPECT), liver function tests (LFT), blood chemistry, renal function tests, and complete blood count. 10. Age \>/= 18 years but \</= 85 years. 11. A signed specific informed consent form before study entry. Exclusion Criteria: 1. Small cell histology. 2. Prior thoracic radiotherapy to regions that would result in overlap of radiation therapy fields. 3. Pregnancy (female patients of childbearing potential must practice appropriate contraception). 4. Enrollment in a clinical trial that specifically excludes IGAPT treatment. 5. Body weight exceeds the weight limit of the treatment couch. 6. Oxygen dependent due to preexistent lung disease (COPD, emphysema, lung fibrosis).
References
Publications (4)
- DERIVEDKoutroumpakis E, Xu T, Lopez-Mattei J, Pan T, Lu Y, Irizarry-Caro JA, Mohan R, Zhang X, Meng QH, Lin R, Xu T, Deswal A, Liao Z. Coronary artery calcium score on standard of care oncologic CT scans for the prediction of adverse cardiovascular events in patients with non-small cell lung cancer treated with concurrent chemoradiotherapy. Front Cardiovasc Med. 2022 Dec 2;9:1071701. doi: 10.3389/fcvm.2022.1071701. eCollection 2022. PMID 36531700
- DERIVEDCella L, Monti S, Xu T, Liuzzi R, Stanzione A, Durante M, Mohan R, Liao Z, Palma G. Probing thoracic dose patterns associated to pericardial effusion and mortality in patients treated with photons and protons for locally advanced non-small-cell lung cancer. Radiother Oncol. 2021 Jul;160:148-158. doi: 10.1016/j.radonc.2021.04.025. Epub 2021 May 9. PMID 33979653
- DERIVEDGjyshi O, Xu T, Elhammali A, Boyce-Fappiano D, Chun SG, Gandhi S, Lee P, Chen AB, Lin SH, Chang JY, Tsao A, Gay CM, Zhu XR, Zhang X, Heymach JV, Fossella FV, Lu C, Nguyen QN, Liao Z. Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC. J Thorac Oncol. 2021 Feb;16(2):269-277. doi: 10.1016/j.jtho.2020.10.013. Epub 2020 Oct 22. PMID 33198942
- DERIVEDLiao Z, Lee JJ, Komaki R, Gomez DR, O'Reilly MS, Fossella FV, Blumenschein GR Jr, Heymach JV, Vaporciyan AA, Swisher SG, Allen PK, Choi NC, DeLaney TF, Hahn SM, Cox JD, Lu CS, Mohan R. Bayesian Adaptive Randomization Trial of Passive Scattering Proton Therapy and Intensity-Modulated Photon Radiotherapy for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Jun 20;36(18):1813-1822. doi: 10.1200/JCO.2017.74.0720. Epub 2018 Jan 2. PMID 29293386