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

NCT01770418 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: LUN005-12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

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.

Conditions

Lung Neoplasms

Keywords

Non Small Cell Lung Cancer; Cancer; Lung; Proton; Radiation

Outcome Measures

Primary Outcomes (2)

• Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.

  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

  At 12 months

Secondary Outcomes (2)

• Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy.

  On average every 3 months for 5 years

• Analyze for disease control and overall survival.

  At 2 years and 5 years

Study Arms (1)

Proton Radiotherapy with Chemotherapy

EXPERIMENTAL

Radiation: Radiation with Concurrent Chemotherapy

Interventions

Radiation with Concurrent Chemotherapy RADIATION

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.

Proton Radiotherapy with Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Proton Collaborative Group: lead

Study Sites (6)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555, United States

Location

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

Princeton ProCure Management LLC

Somerset, New Jersey, 08873, United States

Location

Oklahoma Proton Center

Oklahoma City, Oklahoma, 73142, United States

Location

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Brad Hoppe, MD

  Proton Collaborative Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 17, 2013
• Study Start: March 1, 2013
• Primary Completion (Estimated): January 1, 2038
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (6)