Clinical trial · Interventional
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
NCT00875901CI-TRIAL-00057304LU03completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Centrally located lung tumor | Radiation | — | UNRESOLVED |
| Peripherally located lung tumor | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Peripherally located lung tumor
- description
- 12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent
- interventionNames
- Radiation: Peripherally located lung tumor
- type
- EXPERIMENTAL
- label
- Centrally located lung tumor
- description
- 6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent
- interventionNames
- Radiation: Centrally located lung tumor
Primary outcomes (1)
- measure
- Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment. * T1, N0, M0 or T2, N0, M0. (AJCC Lung 7th Edition) * At least 18 years old at the time of consent. * Adequate bone marrow function. * Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection. * If the patient has a large pleural effusion, it must be biopsy negative. Exclusion Criteria: * Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3). * Synchronous primary. * T2 tumors \> 5 cm; T3, T4 primary tumor. * Previous radiotherapy for lung cancer. * Concomitant local, regional, and/or systemic therapy during radiotherapy. * Active systemic, pulmonary, and/or pericardial infection.
References
Publications (23)
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- BACKGROUNDSuzuki K, Nagai K, Yoshida J, Moriyama E, Nishimura M, Takahashi K, Nishiwaki Y. Prognostic factors in clinical stage I non-small cell lung cancer. Ann Thorac Surg. 1999 Apr;67(4):927-32. doi: 10.1016/s0003-4975(99)00140-x. PMID 10320230
- BACKGROUNDvan Rens MT, de la Riviere AB, Elbers HR, van Den Bosch JM. Prognostic assessment of 2,361 patients who underwent pulmonary resection for non-small cell lung cancer, stage I, II, and IIIA. Chest. 2000 Feb;117(2):374-9. doi: 10.1378/chest.117.2.374. PMID 10669677
- BACKGROUNDDosoretz DE, Galmarini D, Rubenstein JH, Katin MJ, Blitzer PH, Salenius SA, Dosani RA, Rashid M, Mestas G, Hannan SE, et al. Local control in medically inoperable lung cancer: an analysis of its importance in outcome and factors determining the probability of tumor eradication. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):507-16. doi: 10.1016/0360-3016(93)90373-4. PMID 8226142
- BACKGROUNDDosoretz DE, Katin MJ, Blitzer PH, Rubenstein JH, Salenius S, Rashid M, Dosani RA, Mestas G, Siegel AD, Chadha TT, et al. Radiation therapy in the management of medically inoperable carcinoma of the lung: results and implications for future treatment strategies. Int J Radiat Oncol Biol Phys. 1992;24(1):3-9. doi: 10.1016/0360-3016(92)91013-d. PMID 1324899
- BACKGROUNDGauden S, Ramsay J, Tripcony L. The curative treatment by radiotherapy alone of stage I non-small cell carcinoma of the lung. Chest. 1995 Nov;108(5):1278-82. doi: 10.1378/chest.108.5.1278.