Lung CancerPhase 2NCT00495170
Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Carboplatin, Proton Radiotherapy and Paclitaxel in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. 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?
- Carboplatin, Proton Radiotherapy and Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 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.
- Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease excluding malignant pleural effusion.
- Performance score Karnofsky Performance Status (KPS) 70-100, Weight loss: less or equal to 10% in 6 months prior to diagnosis.
- Patient consented for the protocol
- Induction chemotherapy is allowed.
Who cannot join
- Prior chest radiotherapy.
- 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 (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
- Off study criteria: a) If a patient is found to have distant metastasis during treatment and/or immediate after the treatment (<60 days) indicating inaccurate cancer stage, he or she will be taken off study. b) If a patient does not follow up at MD Anderson and does not forward his or her medical records such as CT, PET/CT, pulmonary function test (PFT) or pathology report as required by protocol, he or she will be taken off study. c) If a patient does not have any required post-treatment evaluation such as images, he or she will be taken off study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.
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.
If you are found to be eligible to take part in this study, you will receive 37 treatments of proton radiotherapy (Monday through Friday for 7 1/2 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. While on study, you will also be receiving weekly standard low-dose chemotherapy possibly followed by full-dose chemotherapy.
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. About 2 teaspoons of blood will be drawn for routine tests.
You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, 6 week follow up is recommended after completion of radiotherapy, then required every 3 months (+1 month) for 2 years, then every 6 months (+1 month) for 3 years, and then once a year for 2 years. You will have imaging tests (chest CT or positron emission computed tomography (PET) scan) and routine blood tests (about 2 teaspoons) at the follow-up visits.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer. A total of 65 patients will be take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- Carboplatin, Proton Radiotherapy, Paclitaxel
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Proton Radiotherapy, Proton Beam, Paclitaxel, Taxol, Carboplatin, Paraplatin, 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.
CarboplatinDrug
Also called paraplatin
2 area under curve (AUC) by vein Weekly
Proton RadiotherapyRadiation
2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).
PaclitaxelDrug
Also called Taxol
50 mg/m^2 by vein Weekly
| Study group | Role | What they receive |
|---|---|---|
| Concurrent proton and Chemotherapy | Experimental | Proton Radiotherapy + Carboplatin + Paclitaxel Receives: Drug: Carboplatin; Radiation: Proton Radiotherapy; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival and Progression Free Survival
The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care.
Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up.
Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years.
Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables.
Measured: The Overall survival (OS): From date 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): From date of registration to the date of first documented progression or death 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 start14 Apr 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 84 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
- NCT00495170
- Sponsor's protocol ID
- 2004-0976
- Other IDs
- NCI-2012-01504
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2007
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Koay EJ, Lege D, Mohan R, Komaki R, Cox JD, Chang JY. Adaptive/nonadaptive proton radiation planning and outcomes in a phase II trial for locally advanced non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1093-100. doi: 10.1016/j.ijrobp.2012.02.041. Epub 2012 Apr 27.
PubMed 22543217
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00495170
- Acronym / sponsor ID
- 2004-0976
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Proton Radiotherapy, Proton Beam, Paclitaxel, Taxol, Carboplatin, Paraplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Apr 2006 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 6 Feb 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 proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.
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.
If you are found to be eligible to take part in this study, you will receive 37 treatments of proton radiotherapy (Monday through Friday for 7 1/2 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. While on study, you will also be receiving weekly standard low-dose chemotherapy possibly followed by full-dose chemotherapy.
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. About 2 teaspoons of blood will be drawn for routine tests.
You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, 6 week follow up is recommended after completion of radiotherapy, then required every 3 months (+1 month) for 2 years, then every 6 months (+1 month) for 3 years, and then once a year for 2 years. You will have imaging tests (chest CT or positron emission computed tomography (PET) scan) and routine blood tests (about 2 teaspoons) at the follow-up visits.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer. A total of 65 patients will be take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent proton and Chemotherapy | Experimental | Drug: Carboplatin, Radiation: Proton Radiotherapy, Drug: PaclitaxelProton Radiotherapy + Carboplatin + Paclitaxel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented NSCLC.
- Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease excluding malignant pleural effusion.
- Performance score Karnofsky Performance Status (KPS) 70-100, Weight loss: less or equal to 10% in 6 months prior to diagnosis.
- Patient consented for the protocol
- Induction chemotherapy is allowed.
Key exclusion criteria (4 listed)
- Prior chest radiotherapy.
- 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 (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
- Off study criteria: a) If a patient is found to have distant metastasis during treatment and/or immediate after the treatment (<60 days) indicating inaccurate cancer stage, he or she will be taken off study. b) If a patient does not follow up at MD Anderson and does not forward his or her medical records such as CT, PET/CT, pulmonary function test (PFT) or pathology report as required by protocol, he or she will be taken off study. c) If a patient does not have any required post-treatment evaluation such as images, he or she will be taken off 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 |
|---|---|---|
| CarboplatinAlso: paraplatin2 area under curve (AUC) by vein Weekly | Drug | Concurrent proton and Chemotherapy |
| Proton Radiotherapy2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks). | Radiation | Concurrent proton and Chemotherapy |
| PaclitaxelAlso: Taxol50 mg/m^2 by vein Weekly | Drug | Concurrent proton and Chemotherapy |
Primary outcome
Overall Survival and Progression Free Survival
Time frame: The Overall survival (OS): From date 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): From date of registration to the date of first documented progression or death up to 5 years.
The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care. Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up. Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years. Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22543217Koay EJ, Lege D, Mohan R, Komaki R, Cox JD, Chang JY. Adaptive/nonadaptive proton radiation planning and outcomes in a phase II trial for locally advanced non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1093-100. doi: 10.1016/j.ijrobp.2012.02.041. Epub 2012 Apr 27.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Proton Radiotherapy and Paclitaxel in people with Lung Cancer, run by M.D. Anderson Cancer Center 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 5 inclusion and 4 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 6 Feb 2019. 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.
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 6 Feb 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): From date 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): From date of registration to the date of first documented progression or death up to 5 years.). 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 NCT00495170, which also lists 1 linked publication.
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 6 Feb 2019.