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Trial record 87 of 45945 for:    intensity

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

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ClinicalTrials.gov Identifier: NCT01134146
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Mesothelioma Radiation: IMRT Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : May 27, 2010
Actual Primary Completion Date : July 9, 2017
Actual Study Completion Date : July 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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 Name: Intensity modulated radiation therapy




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134146


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Study Chair: Daniel Gomez, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01134146     History of Changes
Other Study ID Numbers: 2010-0057
NCI-2011-02080 ( Registry Identifier: NCI CTRP )
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
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:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial