Articles and Resources
Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, May 2010
First Received: May 27, 2010   No Changes Posted

Sponsor:

M.D. Anderson Cancer Center

Information provided by:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT01134146

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:

  1. Patients must have undergone radical pleurectomy/decortication and will be enrolled after surgery.
  2. Patients must have had a CT/PET scan within 45 days 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 16 weeks after pleurectomy/decortication. We anticipate that most patients will begin radiation treatment 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.

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.

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
  More Information

Additional Information:

No publications provided


Responsible Party: UT MD Anderson Cancer Center ( Daniel Gomez, MD / Assistant Professor )
ClinicalTrials.gov Identifier:

NCT01134146    History of Changes

Other Study ID Numbers: 2010-0057
Study First Received: May 27, 2010
Last Updated: May 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Intensity Modulated Radiotherapy
IMRT
Malignant Pleural Mesothelioma
Radical Pleurectomy
Decortication
PD
pleurectomy
lung surgery
pleura

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on August 09, 2010


Source: www.ClinicalTrials.gov