A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD
Outcome Description:
To establish the MTD of a proton beam-based regimen consisting of 25 fractions, together with concurrent standard cisplatin and etoposide chemotherapy followed by surgery +/- adjuvant chemotherapy for Stage III NSCLC, and to describe post-treatment surgical complications and treatment toxicity using CTCAE v4.0
Outcome Time Frame:
1.5 years
Safety Issue:
Yes
Principal Investigator
Henning Willers, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
11-253
NCT ID:
NCT01565772
Start Date:
March 2012
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- Lung cancer
- Stage III
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
