Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu
Trial record 1 of 1 for:    NCT01770418
Previous Study | Return to List | Next Study

A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770418
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : April 4, 2023
Information provided by (Responsible Party):
Proton Collaborative Group

Brief Summary:
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Radiation: Radiation with Concurrent Chemotherapy Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Study Start Date : March 2013
Estimated Primary Completion Date : January 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Proton Radiotherapy with Chemotherapy Radiation: Radiation with Concurrent 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


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.

Primary Outcome Measures :
  1. 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).

  2. Phase II: Determine the percentage of patients that survive at least 12 months [ Time Frame: At 12 months ]

Secondary Outcome Measures :
  1. Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy. [ Time Frame: On average every 3 months for 5 years ]
  2. Analyze for disease control and overall survival. [ Time Frame: At 2 years and 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01770418

Layout table for location information
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
United States, Illinois
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States, 60555
United States, Maryland
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
United States, New Jersey
Princeton ProCure Management LLC
Somerset, New Jersey, United States, 08873
United States, Oklahoma
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States, 73142
United States, Virginia
Hampton University Proton Therapy Institute
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Proton Collaborative Group
Layout table for investigator information
Study Chair: Brad Hoppe, MD Proton Collaborative Group
Layout table for additonal information
Responsible Party: Proton Collaborative Group Identifier: NCT01770418    
Other Study ID Numbers: LUN005-12
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: April 2023
Keywords provided by Proton Collaborative Group:
Non Small Cell Lung Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms