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A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 Grade. 3 Treatment Related Pneumonitis (TRP) in Patients With Locally Advanced Non-Small Cell Lung Carcinoma (NSCLC) Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy (3D CRT, ARM 1) Versus Intensity Modulated Radiation Therapy (IMRT, ARM 2) Using 4-Dimensional CT Planning and Image Guided Adaptive Radiation Therapy (IGART)


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 Grade. 3 Treatment Related Pneumonitis (TRP) in Patients With Locally Advanced Non-Small Cell Lung Carcinoma (NSCLC) Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy (3D CRT, ARM 1) Versus Intensity Modulated Radiation Therapy (IMRT, ARM 2) Using 4-Dimensional CT Planning and Image Guided Adaptive Radiation Therapy (IGART)


TRP (treatment related pneumonitis) is an inflammation (irritated or injured tissue) of the
lungs that occurs as a result of chemotherapy or radiation therapy. TRP occurs because both
chemotherapy and radiation affect normal lung tissue when tumors are being treated.

3D CRT is the current standard of care. It delivers radiation to several different angles of
the body with center focus on the tumor(s). Because it is delivered at different angles, the
same amount of radiation that contacts the tumor(s) also contacts normal lung tissue at each
angle.

IMRT is a new type of radiation therapy. It also delivers radiation to several different
angles of the body with center focus on the tumor(s). The difference is that the amount of
treatment at each angle is adjusted according to the shape and size of the tumor(s), which
in turn may decrease radiation exposure to normal lung tissue at each angle. Researchers
want to find out if intensity modulated radiation therapy (IMRT) is able to decrease the
amount of normal lung that is affected when treating lung cancer.

Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have a
physical exam, including measurement of your vital signs (blood pressure, heart rate,
temperature, and breathing rate). You will have blood drawn (about 1 tablespoon) and urine
collected for routine tests. You will be asked about any other medical problems you may have
that could cause the development of TRP. You will have tests that include a computed
tomography (CT) scan, positron emission tomography (PET) scan, and lung function test. A PET
scan is a scan that will show cells that take in higher levels of a type of sugar (glucose),
such as cancer cells. Before the scan, a small dose of a slightly radioactive form of
glucose will be injected through a vein. The cells that take in higher amounts of glucose
will show up better on the scan. The scanning process is quite similar to a regular CT
scan. No new biopsy is needed; only the original biopsy will be used for this study.

You will have 2 different single photon-emission computed tomography tests (SPECTs). You
will have a lung single-photon emission computerized tomography (SPECT)test that will show
the area of blood flow in the normal lung. You will have a heart single-photon emission
computerized tomography (SPECT) test that will show the areas of blood flow in the heart. To
perform these single-photon emission computerized tomography (SPECT) tests, you will have a
slightly radioactive substance injected into your vein so that images can be seen of the
blood flow in the lung and heart. This will help the study doctor try to avoid using
radiation angles that would go through the normal blood flow area. You will also have a
biopsy of your tumor tissue. To perform a tumor biopsy, an area of the body (where tumor is
present) is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through
a large needle or with forceps (a tong-like instrument) during an endoscopic (viewing of
body cavity with a special instrument) exam.

Researchers will use the results of these tests to learn the stage (size and location) of
the cancer to see if the tumor(s) can be treated by radiation. Women who are able to have
children must have a blood or urine pregnancy test, which will be performed on the same
blood or urine that was collected for routine tests. To be eligible to take part in this
study, the pregnancy test must be negative.

If you are found to be eligible to take part in this study, your radiation doctor will first
conduct a planning session. You will have a CT scan of your chest, and your respiratory
(breathing) motion will be monitored. After the scan is done, your radiation doctor will
evaluate it and make an outline of the tumor(s) in your lung. The CT scan helps the doctor
identify (note the difference between) the tumor(s) and the normal surrounding tissue. The
planning session helps the radiation doctor decide the target area(s), the best angles to
deliver the radiation, and the most effective radiation dose (which is also intended to
decrease radiation to surrounding normal tissues) for treatment.

If the plan for treatment is considered acceptable for you by the radiation doctor, you will
then be randomly assigned (as in the toss of a coin) to 1 of 2 treatment groups.
Participants in one group will receive 3D CRT. Participants in the other group will receive
intensity modulated radiation therapy (IMRT). You will have an equal chance of being in
either one of these groups. If you are assigned to receive intensity modulated radiation
therapy (IMRT), the total radiation dose to the tumor(s) will be slightly higher than for
participants receiving 3D CRT.

If the 3D CRT plan for treatment is not considered acceptable for you (usually because of a
large target area) by the radiation doctor, you will be treated with IMRT, with or without
amifostine. Amifostine is a drug given as an injection to protect the normal lung and
esophagus tissue from radiation side effects and injury. Your treating physician will
decide if you need amifostine or not, based on the size of the tumor tissue and normal
tissue in the radiation "field" (the area given radiation during treatment). If you need
amifostine, a nurse will give you the injection about 30 minutes before radiation treatment.
Your blood pressure will be checked for 15-20 minutes after injection.

Participants on this study will be receiving standard chemotherapy given together with
radiation therapy. The standard chemotherapy usually includes cisplatin, carboplatin,
paclitaxel, or docetaxel. The chemotherapy is not considered the investigational part of
this study.

All study participants will receive standard chemotherapy, given together with radiation
therapy. The standard chemotherapy usually includes cisplatin, carboplatin, paclitaxel,
and/or docetaxel. Your chemotherapy doctor will explain the side effects of these
chemotherapy drugs to you before you start receiving chemotherapy. The chemotherapy is not
the investigational part of this clinical trial.

Participants in each group will receive a total of 6 ½ weeks of radiation therapy (once a
day for 5 days a week). You will not be treated on the weekends or on a national holiday.
If the disease gets worse or you experience any intolerable side effects, you will be taken
off this study.

After you have completed therapy on this study, you will have follow-up visits. The study
doctor will check how the disease responded to treatment using the same imaging scans and
blood tests (about 1 tablespoon each time) that were performed during the screening portion
of this study. These tests will be performed about every 3-4 months after completion of
treatment as part of your standard of care.

This is an investigational study. Both 3D conformal radiation therapy (CRT) and intensity
modulated radiation therapy (IMRT) are FDA approved for the treatment of cancer. Up to 168
patients will take part in this study. All will be enrolled at M.D. Anderson.


Inclusion Criteria:



1. Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell
lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without
contralateral hilar nodal disease.

2. Patient is suitable for concurrent chemoradiation therapy per treating physician's
assessment (kps >/= 70, weight loss < 10% in three months prior to diagnosis).

3. Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal
gland, or one site of bone), who have clinical indication of concurrent
chemoradiation to the primary disease in the lung are eligible.

4. Patients who received induction chemotherapy and then referred for concurrent
chemoradiation are eligible.

5. Patients who had local regional recurrence after surgical resection and who are
suitable for definitive concurrent chemoradiation are eligible.

6. Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan

7. FEV 1> 1000 cc

8. Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a
standard procedure for staging. It is strongly encouraged to have this PET/CT
performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the
department of radiation oncology.

9. Patient will undergo routine standard pretreatment evaluations as decided by treating
physician, which usually include magnetic resonance imaging (MRI) or CT of the brain,
contrast CT scan of the thorax and upper abdomen, pulmonary functional test,
single-photon emission computerized tomography (SPECT), liver function tests (LFT),
blood chemistry, renal functional test, complete blood count.

10. Age > 18, < 80 years

11. Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

1. Evidence of small cell histology

2. Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields

3. Pregnant women are ineligible as the treatment involves unforeseeable risks to the
participant and to the embryo or fetus. Patients with childbearing potential must
practice appropriate contraception.

4. Patient has enrolled in a clinical trial that specifically does not allow IMRT
treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To compare intensity-modulated radiation therapy (IMRT) with three-dimensional conformal radiation therapy (3D CRT) in the ability to decrease the risk of treatment-related pneumonitis (TRP).

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Zhongxing Liao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0222

NCT ID:

NCT00520702

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • 3-Dimensional Conformal Radiation Therapy
  • Intensity Modulated Radiation Therapy
  • 3D CRT
  • IMRT
  • NSCLC
  • TRP
  • Treatment related pneumonitis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030