Locally Advanced Non-Small Cell Lung CancerPhase 1/2NCT00614484
Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
A Phase 1/2 study testing Proton Radiation Therapy, Taxol and Carboplatin in people with Locally Advanced Non-Small Cell Lung Cancer, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer
- What is being tested?
- Proton Radiation Therapy, Taxol and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jun 2011
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stage 2, 3A or 3B (unresectable)
- Histologic evidence of non-small cell carcinoma
- Age > 18 years
- Karnofsky performance status 70 or greater
- No prior radiation to the chest
- No previous chemotherapy
Who cannot join
- Clinical stage 1 or 4
- Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.
- Being tested
- Proton Radiation Therapy, Taxol, Carboplatin
- Keywords
- Proton, Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Radiation TherapyRadiation
A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
TaxolDrug
Also called Paclitaxel
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
CarboplatinDrug
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Proton therapy with chemotherapy | Experimental | Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.
Proton therapy - 76 Gy in 5 weeks to lung tumor. Receives: Radiation: Proton Radiation Therapy; Drug: Taxol; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival.
Median survival time following treatment.
Measured: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Secondary outcomes (1)
Treatment Related Toxicities.
grade 3 or higher esophageal toxicity
Toxicity is categorized either early or late phase.
Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter
Measured: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startAug 1999
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Low participant enrollment rates. Significant comparative data not obtained.
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 Locally Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A. Bush, MD, Principal investigator, Loma Linda University Department of Radiation MedicineJerry D. Slater, MD, Study chair, Loma Linda University Department of Radiation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614484
- Sponsor's protocol ID
- OSR #49168
- Status last verified
- Apr 2014
- First submitted
- 26 Dec 2007
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00614484
- Acronym / sponsor ID
- OSR #49168
- Keywords
- Proton, Radiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low participant enrollment rates. Significant comparative data not obtained.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Aug 1999
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton therapy with chemotherapy | Experimental | Radiation: Proton Radiation Therapy, Drug: Taxol, Drug: CarboplatinInduction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks. Proton therapy - 76 Gy in 5 weeks to lung tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical stage 2, 3A or 3B (unresectable)
- Histologic evidence of non-small cell carcinoma
- Age > 18 years
- Karnofsky performance status 70 or greater
- No prior radiation to the chest
Key exclusion criteria (2 listed)
- Clinical stage 1 or 4
- Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years
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 Radiation TherapyA five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy. | Radiation | Proton therapy with chemotherapy |
| TaxolAlso: Paclitaxel200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy. | Drug | Proton therapy with chemotherapy |
| CarboplatinAUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy. | Drug | Proton therapy with chemotherapy |
Primary outcome
Overall Survival.
Time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Median survival time following treatment.
1 secondary outcome
Treatment Related Toxicities.
Time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David A. Bush, MD principal investigator
Loma Linda University Department of Radiation Medicine
Jerry D. Slater, MD study chair
Loma Linda University Department of Radiation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proton Radiation Therapy, Taxol and Carboplatin in people with Locally Advanced Non-Small Cell Lung Cancer, run by Loma Linda University 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 2 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: stopped early, as of the sponsor's last update on 22 May 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 22 May 2014). 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. (time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 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 22 May 2014.