Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00495040
First received: June 28, 2007
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied.

Objectives:

To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC.

Primary goals:

  1. Improve 2 years progression free survival at the primary site, and
  2. reduce acute and chronic toxicity

Secondary goals:

  1. Improve disease specific survival at 2 years.
  2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
  3. Study the role of biomarkers in predicting therapeutic response and toxicities.

Condition Intervention Phase
Lung Cancer
Radiation: Proton Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Toxicity with escalated/accelerated proton radiotherapy in controlling NSCLC [ Time Frame: Weekly assessment during course of treatment (7-8 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2006
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy
Proton radiotherapy 87.5 CGE with 2.5 Gy/fraction for 35 treatments.
Radiation: Proton Radiotherapy
87.5 CGE with 2.5 Gy/fraction for 35 treatments

Detailed Description:

A proton beam is made up of charged particles that have a well-defined range of penetration into tissues. How deep it can penetrate is decided by both the beam's energy and the density of the tissue through which it passes. As the proton beam penetrates the body, the particles slow down, and the beam deposits its dose sharply near the end of its range. This is a phenomenon known as the Bragg peak. By adjusting the Bragg peak, the doctor can deliver a full, localized, uniform dose of energy to the treatment site while sparing the surrounding normal tissues. The proton beam is ideal for treatments where organ preservation is very important, such as lung cancer. Researchers know that standard photon radiotherapy is not able to adequately control tumor growth. But unfortunately, it is not possible to increase the dose of photon radiotherapy without also significantly increasing the side effects. In this study, using proton radiotherapy, researchers will increase the dose about 40% higher than standard photon radiotherapy.

Screening Tests

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed before starting treatment on this study:

Your complete medical history will be recorded. You will have a physical exam. Blood (about 4 teaspoons) will be drawn (within 30 days) for the routine blood tests You will have a computed tomography (CT) scan or positron emission tomography (PET/CT) scan of the chest, an MRI scan or CT of the brain, You will have a lung function test. Women who are able to have children must have a negative blood-pregnancy test. You will have a 4DCT.

Study Drug Administration If you are found to be eligible to take part in this study, you will receive 35 treatments of proton radiotherapy (radiotherapy does not have to start on a Monday but it cannot start on a Friday; usually Monday through Thursday for 7 to 8 weeks). During the treatment, you will lie still on a table for about 30-45 minutes per day in the same position. The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer. You will not feel, see, or smell anything during the proton beam delivery.

During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. You will have a physical exam and you will have a medical history.

You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, follow up is recommended 6 weeks after completion of radiotherapy, required every 3 months (+/-1 month) for two years, then every (+/-1 month) 6 months for three years, and then once a year for 2 years. You will have imaging tests (chest CT or PET scan), lung function test and routine blood tests (about 2 teaspoons) at the follow-up visits. You are allowed to have further chemotherapy or other treatment while you are still in the follow-up on this study. You should discuss chemotherapy with your medical oncologist.

This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer treatment. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically documented NSCLC.
  2. Patients with inoperable centrally located tumors, defined as those within 2 cm of the bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.
  3. Performance score KPS 60-100.

Exclusion Criteria:

  1. Prior radiotherapy to the chest.
  2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
  3. Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.
  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: NCT00495040

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joe Y. Chang, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00495040     History of Changes
Other Study ID Numbers: 2004-0977
Study First Received: June 28, 2007
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
Proton Radiotherapy
Proton Beam
NSCLC

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

ClinicalTrials.gov processed this record on July 20, 2014