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Trial record 1 of 1 for:    LUN005-12
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A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01770418
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date  ICMJE January 11, 2013
First Posted Date  ICMJE January 17, 2013
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date January 2038   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • 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).
  • Phase II: Determine the percentage of patients that survive at least 12 months [ Time Frame: At 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy. [ Time Frame: On average every 3 months for 5 years ]
  • Analyze for disease control and overall survival. [ Time Frame: At 2 years and 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • Determine the percentage of patients that survive [ Time Frame: At 5 years ]
  • Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy. [ Time Frame: On average every 6 months for 5 years ]
  • Analyze for disease control and overall survival. [ Time Frame: At 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE 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

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.

Study Arms  ICMJE Experimental: Proton Radiotherapy with Chemotherapy
Intervention: Radiation: Radiation with Concurrent Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 10, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2013)
61
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2038   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01770418
Other Study ID Numbers  ICMJE LUN005-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Proton Collaborative Group
Study Sponsor  ICMJE Proton Collaborative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Brad Hoppe, MD Proton Collaborative Group
PRS Account Proton Collaborative Group
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP