Lung CancerPhase 1NCT01134146
Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT)
A Phase 1 study testing IMRT in people with Lung Cancer and Mesothelioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mesothelioma
- What is being tested?
- IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2010to 9 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have undergone radical pleurectomy/decortication and will be enrolled after surgery.
- Patients must have had a CT/PET scan 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Mesothelioma
- Being tested
- IMRT
- Keywords
- Intensity Modulated Radiotherapy, IMRT, Malignant Pleural Mesothelioma, Radical Pleurectomy, Decortication, PD, pleurectomy, lung surgery, pleura
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Also called Intensity modulated radiation therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)
MTD by assessing the toxicity of two different whole-pleura radiation doses.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study start27 May 2010
- Primary completion9 Jul 2017
- Study completion9 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Gomez, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134146
- Sponsor's protocol ID
- 2010-0057
- Other IDs
- NCI-2011-02080
- Status last verified
- Jul 2017
- First submitted
- 27 May 2010
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)
- ClinicalTrials.gov ID
- NCT01134146
- Acronym / sponsor ID
- 2010-0057
- Conditions
- Lung Cancer, Mesothelioma
- Keywords
- Intensity Modulated Radiotherapy, IMRT, Malignant Pleural Mesothelioma, Radical Pleurectomy, Decortication, PD, pleurectomy, lung surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 May 2010 (actual)
- Primary completion
- 9 Jul 2017 (actual)
- Study completion
- 9 Jul 2017 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensity Modulated Radiation Therapy (IMRT) | Experimental | Radiation: IMRTIntensity 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have undergone radical pleurectomy/decortication and will be enrolled after surgery.
- Patients must have had a CT/PET scan 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRTAlso: Intensity modulated radiation therapyDelivery 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 | Intensity Modulated Radiation Therapy (IMRT) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Gomez, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMRT in people with Lung Cancer and Mesothelioma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.