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Trial record 1 of 1 for:    NCT00495040
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Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00495040
Recruitment Status : Completed
First Posted : July 2, 2007
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Massachusetts General Hospital
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Radiation: Proton Radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : May 4, 2006
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Survival and Progression Free Survival [ Time Frame: The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years. ]

    Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS).

    Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495040


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Massachusetts General Hospital
Investigators
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Principal Investigator: Joe Y. Chang, MD, PhD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00495040    
Other Study ID Numbers: 2004-0977
NCI-2012-01503 ( Registry Identifier: NCI CTRP )
P01CA021239-30 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2007    Key Record Dates
Results First Posted: January 14, 2019
Last Update Posted: January 14, 2019
Last Verified: December 2018
Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
Proton Radiotherapy
Proton Beam
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms