Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT)

July 17, 2017 updated by: M.D. Anderson Cancer Center

A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)

The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given to directly to the pleura (the outer lining of the lungs) using intensity modulated radiation therapy (IMRT) in patients with MM who have had a pleurectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy (IMRT) Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Radiation: IMRT
Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Other Names:
  • Intensity modulated radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)
Time Frame: 3 Months
MTD by assessing the toxicity of two different whole-pleura radiation doses.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Daniel Gomez, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2010

Primary Completion (Actual)

July 9, 2017

Study Completion (Actual)

July 9, 2017

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0057
  • NCI-2011-02080 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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