Back to results

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

Primary Purpose

Lung Neoplasms

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Radiation with Concurrent Chemotherapy

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Non Small Cell Lung Cancer, Cancer, Lung, Proton, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Florida Proton Therapy Institute
Northwestern Medicine Chicago Proton Center
Maryland Proton Treatment Center
Princeton ProCure Management LLC
Oklahoma Proton Center
Hampton University Proton Therapy Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiotherapy with Chemotherapy

Arm Description

Outcomes

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.

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

Secondary Outcome Measures

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

Analyze for disease control and overall survival.

Full Information

NCT ID

NCT01770418

First Posted

January 11, 2013

Last Updated

April 1, 2023

Sponsor

Proton Collaborative Group

1. Study Identification

Unique Protocol Identification Number

NCT01770418

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2013 (undefined)

Primary Completion Date

January 2038 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Proton Collaborative Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

Non Small Cell Lung Cancer, Cancer, Lung, Proton, Radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiotherapy with Chemotherapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Radiation with Concurrent Chemotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Weekly until completion of radiation treatment

Title

Phase II: Determine the percentage of patients that survive at least 12 months

Time Frame

At 12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

On average every 3 months for 5 years

Title

Analyze for disease control and overall survival.

Time Frame

At 2 years and 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 > 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brad Hoppe, MD

Organizational Affiliation

Proton Collaborative Group

Official's Role

Study Chair

Facility Information:

Facility Name

University of Florida Proton Therapy Institute

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32206

Country

United States

Facility Name

Northwestern Medicine Chicago Proton Center

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Facility Name

Maryland Proton Treatment Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Princeton ProCure Management LLC

City

Somerset

State/Province

New Jersey

ZIP/Postal Code

08873

Country

United States

Facility Name

Oklahoma Proton Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73142

Country

United States

Facility Name

Hampton University Proton Therapy Institute

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs