- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770418
A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Conventional fractionated photon-based radiotherapy to 60-63 Gy at 1.8-2 Gy/fraction with concurrent chemotherapy remains the standard treatment practice in patients with stage III non-small cell lung carcinoma (NSCLC) with local control rates of approximately 50% and a median overall survival of just 18 months.Unfortunately, even the standard treatment has significant toxicity with approximately 40% of patients developing grade 3 or higher acute toxicities in the RTOG 9410 study.1 These outcomes are poor and more effective treatment regimens are needed.
Higher doses of radiation have been hypothesized to improve local control in patients with stage III NSCLC. This is expected to translate into better overall survival.Given the significant improvements in outcome in patients receiving hypofractionation for stage I NSCLC, perhaps similar gains could be achieved if hypofractionated radiotherapy could be safely delivered to stage II-III NSCLC with concurrent chemotherapy. Hypofractionated radiotherapy may offer improvement in local control compared with conventional fractionation that may translate into improved overall survival. Furthermore, hypofractionation will shorten the time interval during which patients are receiving less aggressive chemotherapy. Proton therapy is a highly conformal radiotherapy technique that takes advantage of the proton's characteristic Bragg Peak, resulting in significant reductions in the exit dose of the treatment beam. Thus, proton therapy can substantially reduce the dose to critical structures even compared with IMRT.
This study will investigate the safety and efficacy of delivering hypofractionated proton therapy with concurrent chemotherapy in patients with stage II-III NSCLC
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32206
- University of Florida Proton Therapy Institute
-
-
Illinois
-
Warrenville, Illinois, United States, 60555
- Northwestern Medicine Chicago Proton Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Maryland Proton Treatment Center
-
-
New Jersey
-
Somerset, New Jersey, United States, 08873
- Princeton ProCure Management LLC
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73142
- Oklahoma Proton Center
-
-
Virginia
-
Hampton, Virginia, United States, 23666
- Hampton University Proton Therapy Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy.
- AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III.
- ECOG Performance status 0-1 within 8 weeks prior to study registration.
- Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment.
- Patient must be at least 18 years old at the time of consent.
- Patient must complete all required tests in section 4.
Lab results per the following within 4 weeks prior to study registration:
- Absolute neutrophil count (ANC) >1,800 cells/mm3.
- Platelets > = 100,000 cells/mm3.
- Hemoglobin > =10 g/dl. The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable.
- AST/SGOT and ALT/SGPT < 2.5 x the institutional upper limit of normal (IULN).
- Post exploratory thoracotomy must be done > 3 weeks prior to study registration or patient did not have post exploratory thoracotomy.
- PFT (pulmonary function test) with a FEV1 > 0.75 liters/second within 16 weeks prior to study registration.
- Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection.
Exclusion Criteria:
- Evidence of distant metastasis (M1) involvement.
- Prior radiotherapy to thoracic area.
- Unintentional weight loss >10% within 4 weeks prior to study registration.
- Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proton Radiotherapy with Chemotherapy
|
RADIATION: Proton Radiotherapy Dose Level 1: 60 Gy (RBE) at 2.5 Gy(RBE) per fraction x 24 fractions Dose Level 2: 60 Gy (RBE) at 3 Gy (RBE) per fraction x 20 fractions Dose Level 3: 60.01 Gy (RBE) at 3.53 Gy (RBE) per fraction x 17 fractions Dose Level 4: 60 Gy (RBE) at 4 Gy (RBE) per fraction x 15 fractions CONCURRENT CHEMOTHERAPY: Paclitaxel at a dose of 45 mg/m2 and Carboplatin at a dose of AUC 2 mg/min/ml (a total of 3-5 weekly doses) OR Cisplatin 50mg/m2 days 1, 8, 29, and 36 and Etoposide 50mg/m2 days 1-5, 29-33. For non squamous histology, Carboplatin AUC 5 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days OR Cisplatin 75 mg/m2 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days. Adjuvant chemotherapy is optional. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.
Time Frame: Weekly until completion of radiation treatment
|
This phase will have a minimum of 2 treated patients and we anticipate that the MTD will be located before a maximum of 28 patients are treated.
The trial begins by treating 5 patients at 2.5 Gy (RBE)/fraction to a dose of 60 Gy (RBE).
|
Weekly until completion of radiation treatment
|
Phase II: Determine the percentage of patients that survive at least 12 months
Time Frame: At 12 months
|
At 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy.
Time Frame: On average every 3 months for 5 years
|
On average every 3 months for 5 years
|
Analyze for disease control and overall survival.
Time Frame: At 2 years and 5 years
|
At 2 years and 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Brad Hoppe, MD, Proton Collaborative Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUN005-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Neoplasms
-
UNC Lineberger Comprehensive Cancer CenterSivan Innovation Ltd.CompletedLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of LungUnited States
-
Baptist Health South FloridaWithdrawnLung Cancer | Lung TumorUnited States
-
Oliver JonasMassachusetts General HospitalCompletedLung Cancer | Lung TumorUnited States
-
C. R. BardCompleted
-
Portsmouth Hospitals NHS TrustCompletedLung Cancer | Interstitial Lung DiseaseUnited Kingdom
-
Azienda Sanitaria-Universitaria Integrata di UdineRecruitingLung Diseases | Lung Cancer | Lung Adenocarcinoma | Lung Transplant Rejection | Lung; Node | Lung TBItaly
-
Point TherapeuticsTerminatedCarcinoma, Non-Small-Cell Lung | Lung Cancer | Neoplasms, Lung | Neoplasms, PulmonaryUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Keimyung University Dongsan Medical CenterCompletedLung Cancer | Lung Diseases, Interstitial
-
University of UtahRecruitingLung Cancer | Lung Neoplasms/DiagnosisUnited States
Clinical Trials on Radiation with Concurrent Chemotherapy
-
The New York Proton CenterRecruitingThoracic CancerUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...Recruiting
-
Zhejiang Cancer HospitalUnknown
-
Clinica Universidad de Navarra, Universidad de...CompletedAdenocarcinoma | Gastrointestinal Neoplasms | Gastric Cancer | Surgery | Effects of ChemotherapySpain
-
Sun Yat-sen UniversityRecruitingNon-small Cell Lung CancerChina
-
Fujian Cancer HospitalNot yet recruitingNasopharyngeal CarcinomaChina
-
Samsung Medical CenterTerminatedLocally Advanced Rectal CancerKorea, Republic of
-
Second Affiliated Hospital, School of Medicine,...UnknownNasopharyngeal Carcinoma | Neoadjuvant ChemotherapyChina
-
Leo W. Jenkins Cancer CenterEast Carolina UniversityTerminated
-
Richard ZellarsActive, not recruitingBreast Cancer | Adenocarcinoma of the BreastUnited States