Intensity-Modulated Scanning Beam Proton Therapy (IMPT) With Simultaneous Integrated Boost (SIB)

Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 17, 2012
End Date:September 2019
Contact:Zhongxing Liao, MD

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Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)

The goal of this clinical research study is to learn if the dose of radiation to the tumor
but not the surrounding healthy tissue could be increased by using intensity-modulated photon
therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).

In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT
that can be given to the tumor.

In Phase II, researchers want to learn if IMPT can help to control the disease compared with
standard proton therapy when both are combined with standard chemotherapy. Participants will
also receive standard chemotherapy. Proton therapy and photon therapy are types of radiation
therapy that are designed to use a beam of proton or photon particles (similar to getting an
x-ray) to send radiation inside the body to the tumor.

In IMPT and IMRT, the amount or strength of the protons or photons will be adjusted according
to the size, shape, and thickness of the tumor. In this study, the tumor will receive a
higher dose by adjusting the energy and scanning time of the protons or photons, which is
called simultaneous integrated boost (SIB). The treatment will be done with image guidance.
This newer type of radiation is designed to give a higher than standard dose of treatment to
the tumor. It is also designed to focus the treatment on the tumor to avoid affecting the
healthy tissue around the tumor as much as standard treatments.

Study Groups:

If participant is found to be eligible to take part in this study, they will be assigned to a
study group based on when they join this study. Up to 5 groups of 3 participants will be
enrolled in the Phase I portion of the study, and up to 100 participants will be enrolled in
Phase II.

If participant is enrolled in the Phase I portion, the dose of radiation therapy they receive
will depend on when they joined this study. The first group of participants will receive the
lowest dose level of radiation therapy. Each new group will receive a higher dose of
radiation therapy than the group before it, if no intolerable side effects were seen. This
will continue until the highest tolerable dose of radiation therapy is found.

If participant is enrolled in the Phase I portion, they will be randomly assigned (as in the
flip of a coin) to receive either IMRT or IMPT. Participant will have an equal chance of
being assigned to either group.

If participant is enrolled in the Phase II portion, they will be randomly assigned (as in the
flip of a coin) to receive either IMRT or IMPT. Participant will have an equal chance of
being assigned to either group. For both IMRT and IMPT, participant will receive the highest
tolerable dose that was tolerated in the phase 1 portion of the trial.

Radiation Therapy Administration:

Participant will first go through the standard radiation treatment planning procedure, called
the marking session. This will include a PET/CT, MRI, or CT scan of the lung. A cradle will
then be made to hold participant in the treatment position. After the marking session, a
radiation plan will be made.

Receiving IMRT and IMPT SIB treatments is very similar to the way a CT scan is performed.
Participant will lie on a table and the treatment machine rotates around them without
touching their body.

Participant will receive up to 6 weeks of photon or proton therapy given 1 time a day, 5 days
a week (Monday through Friday).

Each daily treatment should take about 20-30 minutes to complete. Most of this time is used
to position participant correctly before the machine is turned on. The actual time used to
give the radiation should take about 3-5 minutes each day.


Participant will also receive chemotherapy as part of the standard of care for the disease.
The drugs participant receives will depend on the type of disease and what the study doctor
thinks is in participant's best interest. Participant will sign a separate consent form to
receive these drugs that includes their potential risks and benefits, as well as how they are

Symptom Questionnaire:

Participant will complete a symptom questionnaire. This will be done on the following

- before chemoradiation beings

- each week during chemoradiation

- each week until 16 weeks after chemoradiation is complete

- every other week from Week 16 until 12 weeks after chemoradiation is complete

- at participant's follow-up visits

The symptom questionnaire should take about 10 minutes to complete each time.

Study Visits:

At least 1 time each week during chemoradiation (chemotherapy and radiation):

- Participant will have a physical exam.

- Participant will be asked about any side effects they may have had.

- Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Treatment:

Participant may continue receiving study treatment for up to 6 weeks. Participant will no
longer be able to receive the study treatment if the disease gets worse, if intolerable side
effects occur, or if they are unable to follow study directions.

Follow-Up Visits:

After participant has completed chemoradiation, the study staff will call them 1 time each
month to ask them about any symptoms they may have until 6 months after chemoradiation. Each
phone call should last about 10 minutes.

Participant will have their first follow-up visit 4-8 weeks after they have completed
chemoradiation. Participant will have additional follow-up visits every 3-4 months from then

At participant's first and second follow-up visit:

- Participant will have a physical exam.

- Blood (about 1 teaspoon) will be drawn for routine tests.

- Participant will have PET/CT scans and SPECT scans to check their lungs and heart if the
study doctor thinks it is needed.

The remaining follow-up visits will include standard tests, a physical exam, and procedures
that the doctor thinks are needed. For example, PET/CT and SPECT scans will be repeated any
time the study doctor thinks they are needed.

This is an investigational study. Photon therapy by IMRT and proton therapy by IMPT are
delivered using FDA-approved and commercially available methods. It is investigational to use
SIB of IMRT and IMPT to learn if it is a better way to give a higher dose of treatment to the
tumor while not damaging as much of the healthy tissue around it.

Up to 100 will be enrolled at MD Anderson.

Inclusion Criteria:

1. Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after
surgical resection non-small cell lung cancer

2. Suitability for concurrent chemoradiation therapy per treating physician's assessment

3. Karnofsky Performance Status (KPS) score >/=70, weight loss <15% in the 3 months
before diagnosis

4. Prior receipt of induction chemotherapy followed by referral for concurrent
chemoradiation is allowed

5. Adequate lung function indicated by forced expiratory volume at 1 second (FEV)1 >/=1 L
is required

6. The primary tumor and/or regional lymph nodes must be evaluable radiographically

7. The GTV motion should be mm using gating or breath-holding. In addition, the target coverage and normal tissue
constraints must be met as specified in protocol accounting for the respiratory motion
of anatomy as a whole (not just the tumor).

8. Age >/= 18 years

9. No prior radiation to the mediastinal structures

10. Adequate bone marrow, liver and renal function, as assessed by the following:
*Hemoglobin >/=9.0 g/dL *Absolute neutrophil count (ANC) >/=1,500/mm3 *Platelet count
>/=100,000/mm3 *Total bilirubin and aspartate transaminases (ALT and AST) patients with liver involvement) *Creatinine
11. Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of MD Anderson Cancer
Center (MDACC). The only approved consent form is attached to this protocol.

Exclusion Criteria:

1. Prior radiotherapy to any anatomic regions that would result in overlap of radiation
dose distribution to critical structures (esophagus, heart, spinal cord, brachial

2. T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart

3. GTV motion >5 mm on four-dimensional computed tomography (4D CT) scanning with or
without respiratory management using gating or breath-holding

4. Pregnancy (because the treatment involves unforeseeable risks to the participant and
to the embryo or fetus)

5. Patients of childbearing potential must practice appropriate contraception

6. Patient refusal
We found this trial at
1515 Holcombe Blvd
Houston, Texas 77030
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Houston, TX
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