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

NCT01134146 | Completed Phase 1

• 2 other identifiers: 2010-0057NCI-2011-02080
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Mesothelioma

Keywords

Intensity Modulated Radiotherapy; IMRT; Malignant Pleural Mesothelioma; Radical Pleurectomy; Decortication; PD; pleurectomy; lung surgery; pleura

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)

  MTD by assessing the toxicity of two different whole-pleura radiation doses.

  3 Months

Study Arms (1)

Intensity Modulated Radiation Therapy (IMRT)

EXPERIMENTAL

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

Interventions

IMRT RADIATION

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.

Also known as: Intensity modulated radiation therapy

Intensity Modulated Radiation Therapy (IMRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have undergone radical pleurectomy/decortication and will be enrolled after surgery.
• Patients must have had a CT/PET scan prior to surgery
• 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 18 weeks after pleurectomy/decortication. We anticipate that most patients will be ready for radiation simulation between 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.
• 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.

You may not qualify if:

• 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. 4) Patients that have NCCN classified low-risk prostate cancer

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Mesothelioma; Mesothelioma, Malignant

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Daniel Gomez, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: May 27, 2010
• Primary Completion: July 9, 2017
• Study Completion: July 9, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)