Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | June 2015 |
A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
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).
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).
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
