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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01770418
First received: January 11, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Lung Neoplasms
Radiation: Radiation Concurrent Chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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).

  • Phase II: Determine the percentage of patients that survive at least 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy. [ Time Frame: On average every 3 months for 5 years ] [ Designated as safety issue: Yes ]
  • Analyze for disease control and overall survival. [ Time Frame: At 2 years and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: March 2013
Estimated Primary Completion Date: January 2038 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy with Chemotherapy Radiation: Radiation 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

CONCURRENT CHEMOTHERAPY:

Paclitaxel and Carboplatin or Cisplatin and Etoposide 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.

Adjuvant chemotherapy is optional .


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 > 1 liters/second within 16 weeks prior to study registration.

Exclusion Criteria:

  • Evidence of distant metastasis (M1) involvement.
  • Prior radiotherapy to thoracic area.
  • Unintentional weight loss >10% within 4 weeks prior to study registration.
  • Previous or concomitant malignancy within 3 years other than:

    • Curatively treated carcinoma in situ of the cervix, breast, or oral cavity.
    • Basal or squamous cell carcinoma of the skin.
    • Curatively treated superficial transitional cell carcinoma of the urinary bladder.
    • Low risk (T1c-T2a and PSA<10ng/ml and Gleason score <7) prostate cancer.
    • Other early stage tumor treated more than 2 years ago for cure.
  • Prior tumor resection.
  • On home oxygen therapy (intermittent or continuous).
  • 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. Please document as such.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770418

Contacts
Contact: Megan Dunn, PhD,MSHS 630-657-0092 mdunn@pcgresearch.org

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Judy Taylor-Holland    904-588-1401      
Contact: Rochelle Carver    904-588-1475    rcarver@floridaproton.org   
Principal Investigator: Brad Hoppe, MD         
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Research Coordinator    630-821-6397      
Principal Investigator: John Chang, MD         
United States, New Jersey
Princeton ProCure Management LLC Recruiting
Somerset, New Jersey, United States, 08873
Contact: Carl Brown    732-357-2676    carl.brown@nj.procure.com   
Principal Investigator: Brian Chon, MD         
United States, Oklahoma
ProCure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tisha Adams, MS,CCRC    405-773-6775    tisha.adams@okc.procure.com   
Principal Investigator: Gary Larson, MD         
United States, Virginia
Hampton University Proton Therapy Institute Recruiting
Hampton, Virginia, United States, 23666
Contact: Scott Acker    757-251-6856    scott.acker@hamptonproton.org   
Principal Investigator: Christopher Sinesi, MD         
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Brad Hoppe, MD Proton Collaborative Group
  More Information

No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01770418     History of Changes
Other Study ID Numbers: LUN005-12
Study First Received: January 11, 2013
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
Non Small Cell Lung Cancer
Cancer
Lung
Proton
Radiation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014