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A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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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

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

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:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


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:


Principal Investigator

Henning Willers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Stage III
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617