Lung CancerNCT01386697
DIBH Proton Planning
An observational study of Lung Cancer and Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The overall objective is to estimate the actual or potential benefit of deep inspiration breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3 dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT), as it relates to variability in tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer, Gastrointestinal
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2013
- Phase
- Observational
- 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
Study population: This registry study will enroll patients who are 18 years of age or older who select to undergo external beam radiation therapy as definitive or adjuvant treatment for their diagnosis of lung, breast, gastropintestinal or lymphomatous malignancies in the Department of Radiation Oncology.
Who may be able to join
- Age 18 and older
- Biopsy-proven malignancy
- The diagnosis of hepatocellular carcinoma may be made on a clinical basis without the need for a biopsy if the following criteria are met: a) Documentation of hepatitis B or C infection b)Liver mass with characteristic imaging (CT or MRI) features of hepatocellular carcinoma c) Alpha-feta protein (AFP) level greater than 20 ng/mL 3. Planned curative external beam RT as part of the patients treatment for the cancer diagnosis.
- Subject must be cable of giving informed consent for standard external beam radiation therapy as well as for the study.
- Subjects must be able to tolerate the deep inspiration breath hold (DIBH) training and procedures.
Who cannot join
- Subjects unsuitable for or unable to undergo definitive external beam, radiation therapy for their diagnosis of cancer
- Subjects undergoing radiation with palliative (i.e., non-curative) intent.
- Subjects unwilling to undergo simulation with the SpiroDynrX (SDX) system.
- Subjects unable to hold their breath for a minimum of 10 seconds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Prospective Radiation Oncology Planning Study For Lung, Gastrointestinal And Lymphomatous Malignancies Using Proton Radiotherapy As Compared To 3D Conformal And Intensity-Modulated X-Ray Therapy For Dosimetric Evaluation Of Tumoral Coverage And Dose To Organs-At-Risk.
The overall objective is to estimate the actual or potential benefit of deep inspiration breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3 dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT), as it relates to variability in tumor localization, treatment margins, target volume definition, doses to organs at risk and variations with treatment planning.
Read the detailed description
Image acquisition and treatment under deep inspiration breath hold (DIBH) has been demonstrated to reduce treated volumes and doses to organs at risk (OARs) for photon radiotherapy but has not been investigated in the context of proton radiotherapy. The objective of this registry study is to prospectively evaluate deep inspiration breath hold CT scans for use in proton radiotherapy treatment planning and obtain dosimetric data to assess for changes in target volume, planning volumes and doses both to tumor and organs at risk using the SpiroDynrX (SDX) deep inspiration breath hold system as compared to free breathing and 4D CT scans. Patients will be treated with photon therapy. This is a prospective non-randomized, single arm, single institution registry study of patients undergoing definitive external beam photon radiotherapy in our department. Deep inspiration breath hold CT scans will be obtained in our department in the treatment position at the time of CT simulationin addition to the currently obtained free breathing and 4D CT scans. These scans will all be co-registered with the treatment planning CT. Treatment planning volumes will be delineated by the physician and compared to the results and data for our current standard of care utilizing 4D CT scans. Patients will be treated with breath hold CT using photon radiotherapy but we will prospectively create proton treatment plans which will also be compared to the photon treatment plans used for actual treatment. Variability in tumor localization, target volume definition, doses to organs at risk and treatment planning particularities will be summarized and reported across several modalities, including: 3 dimensional conformal radiation therapy (3DCRT), intensity-modulated x-ray therapy (IMXT) and proton therapy. Correlations will be statistically analyzed and reported in terms of minimum, maximum, average and standard deviation, and other dose volume histogram parameters, and where appropriate, compared with appropriate statistical methods (for example, student t-test).
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Plastaras, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386697
- Sponsor's protocol ID
- UPCC 13910
- Status last verified
- Mar 2020
- First submitted
- 30 Jun 2011
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Radiation Oncology Planning Study For Lung, Gastrointestinal And Lymphomatous Malignancies Using Proton Radiotherapy As Compared To 3D Conformal And Intensity-Modulated X-Ray Therapy For Dosimetric Evaluation Of Tumoral Coverage And Dose To Organs-At-Risk.
- ClinicalTrials.gov ID
- NCT01386697
- Acronym / sponsor ID
- UPCC 13910
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Jul 2011 (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 overall objective is to estimate the actual or potential benefit of deep inspiration breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3 dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT), as it relates to variability in tumor localization, treatment margins, target volume definition, doses to organs at risk and variations with treatment planning.
Detailed description
Image acquisition and treatment under deep inspiration breath hold (DIBH) has been demonstrated to reduce treated volumes and doses to organs at risk (OARs) for photon radiotherapy but has not been investigated in the context of proton radiotherapy. The objective of this registry study is to prospectively evaluate deep inspiration breath hold CT scans for use in proton radiotherapy treatment planning and obtain dosimetric data to assess for changes in target volume, planning volumes and doses both to tumor and organs at risk using the SpiroDynrX (SDX) deep inspiration breath hold system as compared to free breathing and 4D CT scans. Patients will be treated with photon therapy. This is a prospective non-randomized, single arm, single institution registry study of patients undergoing definitive external beam photon radiotherapy in our department. Deep inspiration breath hold CT scans will be obtained in our department in the treatment position at the time of CT simulationin addition to the currently obtained free breathing and 4D CT scans. These scans will all be co-registered with the treatment planning CT. Treatment planning volumes will be delineated by the physician and compared to the results and data for our current standard of care utilizing 4D CT scans. Patients will be treated with breath hold CT using photon radiotherapy but we will prospectively create proton treatment plans which will also be compared to the photon treatment plans used for actual treatment. Variability in tumor localization, target volume definition, doses to organs at risk and treatment planning particularities will be summarized and reported across several modalities, including: 3 dimensional conformal radiation therapy (3DCRT), intensity-modulated x-ray therapy (IMXT) and proton therapy. Correlations will be statistically analyzed and reported in terms of minimum, maximum, average and standard deviation, and other dose volume histogram parameters, and where appropriate, compared with appropriate statistical methods (for example, student t-test).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This registry study will enroll patients who are 18 years of age or older who select to undergo external beam radiation therapy as definitive or adjuvant treatment for their diagnosis of lung, breast, gastropintestinal or lymphomatous malignancies in the Department of Radiation Oncology.
Key inclusion criteria (5 listed)
- Age 18 and older
- Biopsy-proven malignancy
- The diagnosis of hepatocellular carcinoma may be made on a clinical basis without the need for a biopsy if the following criteria are met: a) Documentation of hepatitis B or C infection b)Liver mass with characteristic imaging (CT or MRI) features of hepatocellular carcinoma c) Alpha-feta protein (AFP) level greater than 20 ng/mL 3. Planned curative external beam RT as part of the patients treatment for the cancer diagnosis.
- Subject must be cable of giving informed consent for standard external beam radiation therapy as well as for the study.
- Subjects must be able to tolerate the deep inspiration breath hold (DIBH) training and procedures.
Key exclusion criteria (4 listed)
- Subjects unsuitable for or unable to undergo definitive external beam, radiation therapy for their diagnosis of cancer
- Subjects undergoing radiation with palliative (i.e., non-curative) intent.
- Subjects unwilling to undergo simulation with the SpiroDynrX (SDX) system.
- Subjects unable to hold their breath for a minimum of 10 seconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Mar 2020.
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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.
John Plastaras, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 5 inclusion and 4 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 10 Mar 2020. 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.
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.
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 10 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.