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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation
Cisplatin
Etoposide
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Lung cancer, Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation, Chemotherapy and Surgery

Arm Description

Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.

Outcomes

Primary Outcome Measures

MTD
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
To describe pathological downstaging and response following preoperative proton radiation and cisplatin/etoposide chemotherapy
Biomarkers
To explore the predicitive value of biomarkers for radio- and chemosensitization in pre-treatment tumor biopsies and surgical specimens.
Tumor Control and Survival Rates
To evaluate local and regional tumor control rates, progression free survival (PFS) rates, and overall survival rates and 2 and 5 years

Full Information

First Posted
March 26, 2012
Last Updated
February 12, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01565772
Brief Title
Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Lung cancer, Stage III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation, Chemotherapy and Surgery
Arm Type
Experimental
Arm Description
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation
Intervention Description
45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
50 mg/m2 IV on days 1, 8 of cycles 1 and 2
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
50 mg/m2 IV on days 1-5 on Cycles 1-2
Primary Outcome Measure Information:
Title
MTD
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
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Downstaging and Response
Description
To describe pathological downstaging and response following preoperative proton radiation and cisplatin/etoposide chemotherapy
Time Frame
1.5 years
Title
Biomarkers
Description
To explore the predicitive value of biomarkers for radio- and chemosensitization in pre-treatment tumor biopsies and surgical specimens.
Time Frame
1.5 years
Title
Tumor Control and Survival Rates
Description
To evaluate local and regional tumor control rates, progression free survival (PFS) rates, and overall survival rates and 2 and 5 years
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Willers, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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