A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)
18 Years
N/A
Both
Lung Cancer, Mesothelioma
Trial Information
A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)
IMRT:
IMRT is a technique to deliver radiation that allows the radiation beam to be shaped around
the target area.
Radiation Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to receive
one of two doses of radiation therapy based on when you joined the study. If the first dose
is tolerated well by the first group of participants in this study, then the next group of
participants will receive the second, higher dose of radiation.
Practice Visit:
You will have a practice radiation visit about 6-14 weeks after your surgery. At this visit,
you will have a computed tomography (CT) scan that will be used by the study staff to target
where you will receive the IMRT.
A mold will also be made around your body and marks will be made on your skin to help
position your body correctly for the IMRT. This practice visit should take about 1-2 hours.
IMRT Visits:
Two (2) weeks after the practice radiation visit, you will begin receiving IMRT. At each
visit, you will lie down in the mold of your body that was made at the practice visit and
you will be lined up for the IMRT using the marks made at the practice visit. The IMRT will
then be delivered. You will receive IMRT every weekday (Monday-Friday) for up to 5 weeks.
These visits should last about 45-60 minutes.
Study Visits:
The following tests and procedures will be performed 1 time every week for up to 5 weeks
while you are on study:
- You will have a physical and skin exam.
- You will have lung function tests.
You will also have a chest x-ray and a four-dimensional (4D) CT scan to check the status of
the disease during the last week that you are receiving IMRT. A 4D CT scan is performed
just like a CT scan, but during the 4D CT scan, a small black box (about the size of a deck
of cards) will be placed on your abdomen. This box will allow more views of the tumor to be
seen during the scan by the study staff.
Length of Study:
You may receive IMRT for up to 5 weeks. The IMRT will be stopped early if the disease gets
worse or intolerable side effects occur.
Follow-up Visits:
One (1) month after your last dose of IMRT, you will have a chest x-ray, lung function
tests, 4D CT scan and a physical exam. The chest x-ray and CT scan will be performed to
check the status of the disease.
Two (2) months after your last dose of IMRT, you will have a chest x-ray and a physical
exam.
Three (3) months after your last dose of IMRT, you will have a chest x-ray, lung function
tests, a physical exam, a 4D CT scan and a regular CT scan of your chest. The chest x-ray
and CT scans will be performed to check the status of the disease.
Long-term Follow-up:
Every 3 months for 2 years, every 6 months for the next 3 years, and 1 time every year after
that, you will have lung function tests, a physical exam, and alternating CT and positron
emission tomography (PET) scans to check the status of the disease. This means that if you
have a CT scan at one visit, you will have a PET scan at the next visit, or vice versa.
This is an investigational study. IMRT given directly to the pleura in patients with MM
after a pleurectomy is currently being used for research purposes only.
Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients must have undergone radical pleurectomy/decortication and will be enrolled
after surgery.
2. Patients must have had a CT/PET scan prior to surgery
3. Patients will have baseline pulmonary function tests and a quantitative V/Q scan
prior to radiation therapy, and then pulmonary function tests one month and three
months after the completion of radiation. To be conservative, we will assume that the
ipsilateral lung will be nonfunctional after radiation treatment. Therefore, our
inclusion criteria for baseline pulmonary function tests are very similar to those
that we require prior to an extrapleural pneumonectomy, and are as follows:
4. FEV1 >/= 30% of predicted postoperative (ppoFEV1) (as if the patient underwent a
pneumonectomy) based on the following formula using the quantitative V/Q scan: -
Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the
quantitative V/Q scan report.
5. DLCO > 35% predicted
6. Patients must be able to lie flat for the duration of the treatment planning sessions
and treatment.
7. Patients must be adequately recovered from surgery and prepared to begin radiation
therapy 18 weeks after pleurectomy/decortication. We anticipate that most patients
will be ready for radiation simulation between 8-16 weeks after surgery.
8. Patients who have received induction chemotherapy will be included in the study.
9. **Note that 2- 6 represent standard criteria for the delivery of radiation therapy
after pleurectomy/decortication, and are not novel criteria for the purposes of this
protocol.
10. Age >/= 18.
11. All women of childbearing potential (A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 12 consecutive months [i.e., who has had menses at any
time in the preceding 12 consecutive months]) and male participants must practice
effective contraception (abstinence, oral, injectable, or implantable hormonal
contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
spermicide; or vasectomized partner) throughout the study.
12. Calculated glomerular filtration rate of 80 mL/min/1.73m^2 with at least 40% of renal
contribution from the kidney contralateral to the treated hemithorax, as demonstrated
by a pre-radiation renal scan.
Exclusion Criteria:
1. Patients having previous radiation therapy to the low neck, thorax or upper abdomen,
unless the previous radiation therapy is clearly out of the current radiation field,
as determined by the treating physician
2. Patients with metastatic disease.
3. Patients with any of the following conditions: 1) concomitant malignancies other than
squamous cell or basal cell carcinoma of the skin, 2) Carcinoma in situ of the
cervix, 3) Uncontrolled acute congestive heart failure defined by New York Heart
Association Class III or IV. 4) Patients that have NCCN classified low-risk prostate
cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)
Outcome Description:
MTD by assessing the toxicity of two different whole-pleura radiation doses.
Outcome Time Frame:
3 Months
Safety Issue:
No
Principal Investigator
Daniel Gomez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0057
NCT ID:
NCT01134146
Start Date:
May 2010
Completion Date:
Related Keywords:
- Lung Cancer
- Mesothelioma
- Intensity Modulated Radiotherapy
- IMRT
- Malignant Pleural Mesothelioma
- Radical Pleurectomy
- Decortication
- PD
- pleurectomy
- lung surgery
- pleura
- Lung Neoplasms
- Mesothelioma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
