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

Purpose

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 malignant mesothelioma (MM) who have had a pleurectomy.

Condition	Intervention	Phase
Lung Cancer Mesothelioma	Radiation: IMRT	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Mesothelioma

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
MTD by assessing the toxicity of two different whole-pleura radiation doses.

Arms	Assigned Interventions
IMRT: Experimental Intensity Modulated Radiation Therapy (IMRT)	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Estimated Enrollment:	22
Study Start Date:	May 2010
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Criteria
Inclusion Criteria:

Patients must have undergone radical pleurectomy/decortication and will be enrolled after surgery.
Patients must have had a CT/PET scan within 45 days prior to surgery
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:
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.
DLCO > 35% predicted
Patients must be able to lie flat for the duration of the treatment planning sessions and treatment.
Patients must be adequately recovered from surgery and prepared to begin radiation therapy 16 weeks after pleurectomy/decortication. We anticipate that most patients will begin radiation treatment 8-16 weeks after surgery.
Patients who have received induction chemotherapy will be included in the study.
**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.
Age >/= 18.
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.

Exclusion Criteria:

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
Patients with metastatic disease.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134146

Contacts

Contact: Daniel Gomez, MD

713-563-2300

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel Gomez, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:

Daniel Gomez, MD

UT MD Anderson Cancer Center