Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
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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 |
- 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
- 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: | November 2014 (Final data collection date for primary outcome measure) |
-
Radiation: Proton Beam Radiation
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 |
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| Contact: Henning Willers, MD | 617-643-4970 | hwillers@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Principal Investigator: Henning Willers, MD | |
| 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: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Lung cancer Stage III |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013