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

This study is currently recruiting participants.
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henning Willers, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01565772
First received: March 26, 2012
Last updated: January 31, 2013
Last verified: January 2013

March 26, 2012
January 31, 2013
March 2012
November 2014   (final data collection date for primary outcome measure)
MTD [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01565772 on ClinicalTrials.gov Archive Site
  • Downstaging and Response [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To describe pathological downstaging and response following preoperative proton radiation and cisplatin/etoposide chemotherapy
  • Biomarkers [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To explore the predicitive value of biomarkers for radio- and chemosensitization in pre-treatment tumor biopsies and surgical specimens.
  • Tumor Control and Survival Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate local and regional tumor control rates, progression free survival (PFS) rates, and overall survival rates and 2 and 5 years
Same as current
Not Provided
Not Provided
 
Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
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).

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Radiation: Proton Beam Radiation
    45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks
  • Drug: Cisplatin
    50 mg/m2 IV on days 1, 8 of cycles 1 and 2
  • Drug: Etoposide
    50 mg/m2 IV on days 1-5 on Cycles 1-2
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Henning Willers, MD 617-643-4970 hwillers@partners.org
United States
 
NCT01565772
11-253
Yes
Henning Willers, M.D., Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Henning Willers, MD Massachusetts General Hospital
Massachusetts General Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP