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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 7, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Radiation: Proton Beam Radiation
Drug: Cisplatin
Drug: Etoposide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 18
Study Start Date: March 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation, Chemotherapy and Surgery
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565772

Contacts
Contact: Henning Willers, MD 617-643-4970 hwillers@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Henning Willers, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Henning Willers, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Henning Willers, M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01565772     History of Changes
Other Study ID Numbers: 11-253
Study First Received: March 26, 2012
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Lung cancer
Stage III

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014