Lung CancerPhase 2NCT00495040
Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Proton Radiotherapy in people with Lung Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Proton Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2006to 14 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically documented NSCLC.
- Patients with inoperable centrally located tumors, defined as those within 2 cm of the bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.
- Performance score KPS 60-100.
Who cannot join
- Prior radiotherapy to the chest.
- Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
- Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied.
Objectives:
Read more
To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC.
Primary goals:
- Improve 2 years progression free survival at the primary site, and
- reduce acute and chronic toxicity
Secondary goals:
- Improve disease specific survival at 2 years.
- Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
- Study the role of biomarkers in predicting therapeutic response and toxicities.
Read the detailed description
A proton beam is made up of charged particles that have a well-defined range of penetration into tissues. How deep it can penetrate is decided by both the beam's energy and the density of the tissue through which it passes. As the proton beam penetrates the body, the particles slow down, and the beam deposits its dose sharply near the end of its range. This is a phenomenon known as the Bragg peak. By adjusting the Bragg peak, the doctor can deliver a full, localized, uniform dose of energy to the treatment site while sparing the surrounding normal tissues. The proton beam is ideal for treatments where organ preservation is very important, such as lung cancer. Researchers know that standard photon radiotherapy is not able to adequately control tumor growth. But unfortunately, it is not possible to increase the dose of photon radiotherapy without also significantly increasing the side effects. In this study, using proton radiotherapy, researchers will increase the dose about 40% higher than standard photon radiotherapy.
Screening Tests
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed before starting treatment on this study:
Your complete medical history will be recorded. You will have a physical exam. Blood (about 4 teaspoons) will be drawn (within 30 days) for the routine blood tests You will have a computed tomography (CT) scan or positron emission tomography (PET/CT) scan of the chest, an MRI scan or CT of the brain, You will have a lung function test. Women who are able to have children must have a negative blood-pregnancy test. You will have a 4DCT.
Study Drug Administration If you are found to be eligible to take part in this study, you will receive 35 treatments of proton radiotherapy (radiotherapy does not have to start on a Monday but it cannot start on a Friday; usually Monday through Thursday for 7 to 8 weeks). During the treatment, you will lie still on a table for about 30-45 minutes per day in the same position. The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer. You will not feel, see, or smell anything during the proton beam delivery.
During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. You will have a physical exam and you will have a medical history.
You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, follow up is recommended 6 weeks after completion of radiotherapy, required every 3 months (+/-1 month) for two years, then every (+/-1 month) 6 months for three years, and then once a year for 2 years. You will have imaging tests (chest CT or PET scan), lung function test and routine blood tests (about 2 teaspoons) at the follow-up visits. You are allowed to have further chemotherapy or other treatment while you are still in the follow-up on this study. You should discuss chemotherapy with your medical oncologist.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer treatment. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Proton Radiotherapy
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Proton Radiotherapy, Proton Beam, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton RadiotherapyRadiation
87.5 CGE with 2.5 Gy/fraction for 35 treatments
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiotherapy | Experimental | Proton radiotherapy 87.5 CGE with 2.5 Gy/fraction for 35 treatments. Receives: Radiation: Proton Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival and Progression Free Survival
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS).
Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.
Measured: The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start4 May 2006
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe Y. Chang, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495040
- Sponsor's protocol ID
- 2004-0977
- Other IDs
- NCI-2012-01503, P01CA021239-30
- Status last verified
- Dec 2018
- First submitted
- 28 Jun 2007
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00495040
- Acronym / sponsor ID
- 2004-0977
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Proton Radiotherapy, Proton Beam, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Massachusetts General Hospital
- Study start
- 4 May 2006 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied.
Objectives:
To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC.
Primary goals:
- Improve 2 years progression free survival at the primary site, and
- reduce acute and chronic toxicity
Secondary goals:
- Improve disease specific survival at 2 years.
- Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
- Study the role of biomarkers in predicting therapeutic response and toxicities.
Detailed description
A proton beam is made up of charged particles that have a well-defined range of penetration into tissues. How deep it can penetrate is decided by both the beam's energy and the density of the tissue through which it passes. As the proton beam penetrates the body, the particles slow down, and the beam deposits its dose sharply near the end of its range. This is a phenomenon known as the Bragg peak. By adjusting the Bragg peak, the doctor can deliver a full, localized, uniform dose of energy to the treatment site while sparing the surrounding normal tissues. The proton beam is ideal for treatments where organ preservation is very important, such as lung cancer. Researchers know that standard photon radiotherapy is not able to adequately control tumor growth. But unfortunately, it is not possible to increase the dose of photon radiotherapy without also significantly increasing the side effects. In this study, using proton radiotherapy, researchers will increase the dose about 40% higher than standard photon radiotherapy.
Screening Tests
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed before starting treatment on this study:
Your complete medical history will be recorded. You will have a physical exam. Blood (about 4 teaspoons) will be drawn (within 30 days) for the routine blood tests You will have a computed tomography (CT) scan or positron emission tomography (PET/CT) scan of the chest, an MRI scan or CT of the brain, You will have a lung function test. Women who are able to have children must have a negative blood-pregnancy test. You will have a 4DCT.
Study Drug Administration If you are found to be eligible to take part in this study, you will receive 35 treatments of proton radiotherapy (radiotherapy does not have to start on a Monday but it cannot start on a Friday; usually Monday through Thursday for 7 to 8 weeks). During the treatment, you will lie still on a table for about 30-45 minutes per day in the same position. The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer. You will not feel, see, or smell anything during the proton beam delivery.
During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. You will have a physical exam and you will have a medical history.
You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, follow up is recommended 6 weeks after completion of radiotherapy, required every 3 months (+/-1 month) for two years, then every (+/-1 month) 6 months for three years, and then once a year for 2 years. You will have imaging tests (chest CT or PET scan), lung function test and routine blood tests (about 2 teaspoons) at the follow-up visits. You are allowed to have further chemotherapy or other treatment while you are still in the follow-up on this study. You should discuss chemotherapy with your medical oncologist.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer treatment. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiotherapy | Experimental | Radiation: Proton RadiotherapyProton radiotherapy 87.5 CGE with 2.5 Gy/fraction for 35 treatments. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically documented NSCLC.
- Patients with inoperable centrally located tumors, defined as those within 2 cm of the bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.
- Performance score KPS 60-100.
Key exclusion criteria (3 listed)
- Prior radiotherapy to the chest.
- Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
- Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.
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 |
|---|---|---|
| Proton Radiotherapy87.5 CGE with 2.5 Gy/fraction for 35 treatments | Radiation | Proton Radiotherapy |
Primary outcome
Overall Survival and Progression Free Survival
Time frame: The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS). Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Joe Y. Chang, MD, PhD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton Radiotherapy in people with Lung Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 3 inclusion and 3 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival and Progression Free Survival (time frame: The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.