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Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

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.

If you are found to be eligible to take part in this study, you will receive 37 treatments
of proton radiotherapy (Monday through Friday for 7 1/2 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.
While on study, you will also be receiving weekly standard low-dose chemotherapy possibly
followed by full-dose chemotherapy.

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. About 2 teaspoons of blood will be drawn for routine tests.

You will be taken off study early if the disease gets worse or intolerable side effects
occur. After finishing the treatment, 6 week follow up is recommended after completion of
radiotherapy, then required every 3 months (+1 month) for 2 years, then every 6 months (+1
month) for 3 years, and then once a year for 2 years. You will have imaging tests (chest CT
or PET scan) and routine blood tests (about 2 teaspoons) at the follow-up visits.

This is an investigational study. Proton radiotherapy is FDA approved for the treatment of
lung cancer. A total of 65 patients will be take part in this study. All will be enrolled
at MD Anderson.

Inclusion Criteria:

1. Histologically or cytologically documented NSCLC.

2. Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease
excluding malignant pleural effusion.

3. Performance score KPS 70-100, Weight loss: less or equal to 10% in 6 months prior to

4. Patient consented for the protocol

5. Induction chemotherapy is allowed.

Exclusion Criteria:

1. Prior chest radiotherapy.

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 (men and women) of child bearing potential should use an
effective (for them) method of birth control throughout their participation in this

4. Off study criteria: a) If a patient is found to have distant metastasis during
treatment and/or immediate after the treatment (<60 days) indicating inaccurate
cancer stage, he or she will be taken off study. b) If a patient does not follow up
at MD Anderson and does not forward his or her medical records such as CT, PET/CT,
PFT or pathology report as required by protocol, he or she will be taken off study.
c) If a patient does not have any required post-treatment evaluation such as images,
he or she will be taken off study.

Type of Study:


Study Design:

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

Outcome Measure:

Median Survival Time

Outcome Description:

Median survival time defined as baseline to disease progression.

Outcome Time Frame:

Follow for 2 Years

Safety Issue:


Principal Investigator

Joe Y. Chang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Proton Radiotherapy
  • Proton Beam
  • Paclitaxel
  • Taxol
  • Carboplatin
  • Paraplatin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030