Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer

NCT ID: NCT01565772

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-06-30

Brief Summary

This research study is looking at an alternative way of delivering radiation therapy with protons. Protons are tiny particles with a positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Information from other research studies suggests that proton radiation may help to reduce unwanted side effects from radiation and allow an increase in radiation dose that increase the odds of tumor killing.

The purpose of this study is to determine the safest dose of proton radiation therapy to give in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Detailed Description

Proton radiation will be delivered daily Monday through Friday for 5 weeks. Study therapy will be give as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital.

During the weeks that subjects receive radiation, they will also receive 2 cycles of chemotherapy. Each cycle will last 28 days.

Cisplatin will be give as an IV infusion over 30-60 minutes or 1-2 hours on Days 1 and 8 of Cycles 1 and 2.

Etoposide will be given as an IV infusion over 60 minutes on Days 1, 2, 3, 4, 5 of Cycles 1 and 2.

After radiation and 2 cycles of chemotherapy are completed, subjects may have surgery to remove their tumor.

Following surgery, subjects may receive another 2 cycles of chemotherapy (Cycles 3 and 4). Each cycles lasts 21 days. Cisplatin is given on Day 1. Etoposide is given on Days 1, 2, and 3.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation, Chemotherapy and Surgery

Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.

Group Type: EXPERIMENTAL

Proton Beam Radiation

Intervention Type: RADIATION

45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks

Cisplatin

Intervention Type: DRUG

50 mg/m2 IV on days 1, 8 of cycles 1 and 2

Etoposide

Intervention Type: DRUG

50 mg/m2 IV on days 1-5 on Cycles 1-2

Interventions

Proton Beam Radiation

45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks

Intervention Type: RADIATION

Cisplatin

50 mg/m2 IV on days 1, 8 of cycles 1 and 2

Intervention Type: DRUG

Etoposide

50 mg/m2 IV on days 1-5 on Cycles 1-2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed non-small cell lung cancer with a clinical stage of IIIA
• Candidate for chemoradiation and surgical resection
• Measurable disease
• Life expectancy > 6 months
• Normal organ and marrow function

Exclusion Criteria

• Pregnant or breast-feeding
• Prior therapy for lung cancer with chemotherapy
• Prior chest radiation
• Compromised pulmonary function
• Severe neurovascular disease
• History of high cardiac risk including unstable angina
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, clinically significant or serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of a different malignancy unless disease-free for at least 3 years and at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, non muscle-invasive bladder cancer, basal cell or squamous cell carcinoma of the skin
• Subjects with HIV

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henning Willers, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Willers, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-253

Identifier Type: -

Identifier Source: org_study_id