Non-Small Cell Lung CancerLU03NCT00875901
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
A study testing Peripherally located lung tumor and Centrally located lung tumor in people with Non-Small Cell Lung Cancer, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Peripherally located lung tumor and Centrally located lung tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
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
- Non-Small Cell Lung Cancer
- Being tested
- Peripherally located lung tumor, Centrally located lung tumor
- Keywords
- Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherally located lung tumorRadiation
Also called Proton Radiation
12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)
Centrally located lung tumorRadiation
Also called Proton Radiation
6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)
| Study group | Role | What they receive |
|---|---|---|
| Peripherally located lung tumor | Experimental | 12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent Receives: Radiation: Peripherally located lung tumor |
| Centrally located lung tumor | Experimental | 6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent Receives: Radiation: Centrally located lung tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
Measured: 1 year after the end of radiation therapy
Secondary outcomes (3)
Collect and analyze outcome data on tumor control and survival
Measured: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus
Measured: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
Assess changes in quality of life before and after treatment
Measured: Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startSep 2009
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romaine C Nichols, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875901
- Sponsor's protocol ID
- UFPTI 0901 - LU03
- Acronym
- LU03
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2009
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
PubMed 18287387al-Kattan K, Sepsas E, Fountain SW, Townsend ER. Disease recurrence after resection for stage I lung cancer. Eur J Cardiothorac Surg. 1997 Sep;12(3):380-4. doi: 10.1016/s1010-7940(97)00198-x.
PubMed 9332915Suzuki 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.
PubMed 10320230van 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.
PubMed 10669677Dosoretz 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.
PubMed 8226142Dosoretz 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.
PubMed 1324899Gauden 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.
PubMed 7587429Baumann P, Nyman J, Lax I, Friesland S, Hoyer M, Rehn Ericsson S, Johansson KA, Ekberg L, Morhed E, Paludan M, Wittgren L, Blomgren H, Lewensohn R. Factors important for efficacy of stereotactic body radiotherapy of medically inoperable stage I lung cancer. A retrospective analysis of patients treated in the Nordic countries. Acta Oncol. 2006;45(7):787-95. doi: 10.1080/02841860600904862.
PubMed 16982541Fritz P, Kraus HJ, Blaschke T, Muhlnickel W, Strauch K, Engel-Riedel W, Chemaissani A, Stoelben E. Stereotactic, high single-dose irradiation of stage I non-small cell lung cancer (NSCLC) using four-dimensional CT scans for treatment planning. Lung Cancer. 2008 May;60(2):193-9. doi: 10.1016/j.lungcan.2007.10.005. Epub 2007 Nov 28.
PubMed 18045732Lagerwaard FJ, Haasbeek CJ, Smit EF, Slotman BJ, Senan S. Outcomes of risk-adapted fractionated stereotactic radiotherapy for stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):685-92. doi: 10.1016/j.ijrobp.2007.10.053. Epub 2007 Dec 31.
PubMed 18164849Onishi H, Shirato H, Nagata Y, Hiraoka M, Fujino M, Gomi K, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K, Araki T. Hypofractionated stereotactic radiotherapy (HypoFXSRT) for stage I non-small cell lung cancer: updated results of 257 patients in a Japanese multi-institutional study. J Thorac Oncol. 2007 Jul;2(7 Suppl 3):S94-100. doi: 10.1097/JTO.0b013e318074de34.
PubMed 17603311Timmerman R, McGarry R, Yiannoutsos C, Papiez L, Tudor K, DeLuca J, Ewing M, Abdulrahman R, DesRosiers C, Williams M, Fletcher J. Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4833-9. doi: 10.1200/JCO.2006.07.5937.
PubMed 17050868Xia T, Li H, Sun Q, Wang Y, Fan N, Yu Y, Li P, Chang JY. Promising clinical outcome of stereotactic body radiation therapy for patients with inoperable Stage I/II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):117-25. doi: 10.1016/j.ijrobp.2006.04.013. Epub 2006 Jun 9.
PubMed 16765528Hof H, Muenter M, Oetzel D, Hoess A, Debus J, Herfarth K. Stereotactic single-dose radiotherapy (radiosurgery) of early stage nonsmall-cell lung cancer (NSCLC). Cancer. 2007 Jul 1;110(1):148-55. doi: 10.1002/cncr.22763.
PubMed 17516437Zimmermann FB, Geinitz H, Schill S, Thamm R, Nieder C, Schratzenstaller U, Molls M. Stereotactic hypofractionated radiotherapy in stage I (T1-2 N0 M0) non-small-cell lung cancer (NSCLC). Acta Oncol. 2006;45(7):796-801. doi: 10.1080/02841860600913210.
PubMed 16982542
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00875901
- Acronym / sponsor ID
- LU03 / UFPTI 0901 - LU03
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripherally located lung tumor | Experimental | Radiation: Peripherally located lung tumor12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent |
| Centrally located lung tumor | Experimental | Radiation: Centrally located lung tumor6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripherally located lung tumorAlso: Proton Radiation12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart) | Radiation | Peripherally located lung tumor |
| Centrally located lung tumorAlso: Proton Radiation6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day) | Radiation | Centrally located lung tumor |
Primary outcome
Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
Time frame: 1 year after the end of radiation therapy
3 secondary outcomes
Collect and analyze outcome data on tumor control and survival
Time frame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus
Time frame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
Assess changes in quality of life before and after treatment
Time frame: Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 18287387Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
- Background: PubMed 9332915al-Kattan K, Sepsas E, Fountain SW, Townsend ER. Disease recurrence after resection for stage I lung cancer. Eur J Cardiothorac Surg. 1997 Sep;12(3):380-4. doi: 10.1016/s1010-7940(97)00198-x.
- Background: PubMed 10320230Suzuki 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.
- Background: PubMed 10669677van 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.
- Background: PubMed 8226142Dosoretz 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.
- Background: PubMed 1324899Dosoretz 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.
- Background: PubMed 7587429Gauden 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.
- Background: PubMed 16982541Baumann P, Nyman J, Lax I, Friesland S, Hoyer M, Rehn Ericsson S, Johansson KA, Ekberg L, Morhed E, Paludan M, Wittgren L, Blomgren H, Lewensohn R. Factors important for efficacy of stereotactic body radiotherapy of medically inoperable stage I lung cancer. A retrospective analysis of patients treated in the Nordic countries. Acta Oncol. 2006;45(7):787-95. doi: 10.1080/02841860600904862.
- Background: PubMed 18045732Fritz P, Kraus HJ, Blaschke T, Muhlnickel W, Strauch K, Engel-Riedel W, Chemaissani A, Stoelben E. Stereotactic, high single-dose irradiation of stage I non-small cell lung cancer (NSCLC) using four-dimensional CT scans for treatment planning. Lung Cancer. 2008 May;60(2):193-9. doi: 10.1016/j.lungcan.2007.10.005. Epub 2007 Nov 28.
- Background: PubMed 18164849Lagerwaard FJ, Haasbeek CJ, Smit EF, Slotman BJ, Senan S. Outcomes of risk-adapted fractionated stereotactic radiotherapy for stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):685-92. doi: 10.1016/j.ijrobp.2007.10.053. Epub 2007 Dec 31.
- Background: PubMed 17603311Onishi H, Shirato H, Nagata Y, Hiraoka M, Fujino M, Gomi K, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K, Araki T. Hypofractionated stereotactic radiotherapy (HypoFXSRT) for stage I non-small cell lung cancer: updated results of 257 patients in a Japanese multi-institutional study. J Thorac Oncol. 2007 Jul;2(7 Suppl 3):S94-100. doi: 10.1097/JTO.0b013e318074de34.
- Background: PubMed 17050868Timmerman R, McGarry R, Yiannoutsos C, Papiez L, Tudor K, DeLuca J, Ewing M, Abdulrahman R, DesRosiers C, Williams M, Fletcher J. Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4833-9. doi: 10.1200/JCO.2006.07.5937.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romaine C Nichols, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripherally located lung tumor and Centrally located lung tumor in people with Non-Small Cell Lung Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. (time frame: 1 year after the end of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875901, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.