NCT01565772

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

March 26, 2012

Last Update Submit

February 12, 2016

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung cancerStage III

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Downstaging and Response

    1.5 years

  • Biomarkers

    1.5 years

  • Tumor Control and Survival Rates

    5 years

Study Arms (1)

Radiation, Chemotherapy and Surgery

EXPERIMENTAL

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

Radiation: Proton Beam RadiationDrug: CisplatinDrug: Etoposide

Interventions

Proton Beam RadiationRADIATION

45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks

Radiation, Chemotherapy and Surgery
CisplatinDRUG

50 mg/m2 IV on days 1, 8 of cycles 1 and 2

Radiation, Chemotherapy and Surgery
EtoposideDRUG

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

Radiation, Chemotherapy and Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Proton TherapyCisplatinEtoposide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Henning Willers, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 29, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

US(1)