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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01565772
• Other study ID #: 11-253
• Status: Terminated
• Phase: Phase 1
• First received: March 26, 2012
• Last updated: February 12, 2016
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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
• Etoposide
50 mg/m2 IV on days 1-5 on Cycles 1-2

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1.5 years	Yes
Secondary	Downstaging and Response	To describe pathological downstaging and response following preoperative proton radiation and cisplatin/etoposide chemotherapy	1.5 years	No
Secondary	Biomarkers	To explore the predicitive value of biomarkers for radio- and chemosensitization in pre-treatment tumor biopsies and surgical specimens.	1.5 years	No
Secondary	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	5 years	No