T-cell LymphomaNCT01854112
Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma
An observational study of T-cell Lymphoma, run by Far Eastern Memorial Hospital.
Trial summary
Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One the most widely used TSET techniques consists of six dual fields initially developed at Stanford University 2. Read more about this study
- Who is it for?
- Ages 37 to 37 years, women only
- Conditions the study is for
- T-cell Lymphoma
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2017
- 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 37 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: T-cell lymphoma
Who may be able to join
- T-cell lymphoma
Who cannot join
- -
About this study
Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One the most widely used TSET techniques consists of six dual fields initially developed at Stanford University 2. Dosimetrically, TSET at energies of about 3-7 MeV at the surface of a standing patient may result in significant dose variations due to variable skin distance, self shielding, irradiated fields overlapping and patient motion. Deviations occur from the prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid, are revealed in the literature. To improve this condition, a selection of patients with advanced skin disease and regional extension could be cured by a combination of TSEB and photon beam irradiation.
Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length of up to 160 cm, continuously in a helical pattern without the need for field junction. Total marrow irradiation (TMI) via HT with low toxicities for bone marrow transplantation of Asia multiple myeloma patients could be feasible . A study of HT for total scalp irradiation has also shown that the employment of directional and complete blocking on the inner structures can effectively force the tangential delivery of the majority of beamlets to the PTV, which can limit the treatment depth.
Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSI technique to increase dose delivery and decrease toxicities could be a workable and feasible. Here, we applied TSI via HT (HITS) for a woman with T cell lymphoma failure by chemotherapy, topic UV irradiation and local radiotherapy (RT) in MMH to overcome the surface dose inhomogeneity by conventional RT. Additionally, we will compare the advantages and disadvantages between the plan of HT and conventional RT for TSI.
Read the detailed description
Helical tomotherapy planning
Patient will dress the diving suit (3 mm thick) to create bolus effect. AccuFix™ Cantilever Board™ with shoulder depression and thermoplastic fixation were used for head and shoulder immobilization. BlueBagTM immobilization system (Medical Intelligence) was used to fix main trunk and extremities. Both immobilization systems provide a consistent treatment position from the initial computed tomography (CT) scanning, pretreatment megavoltage CT (MVCT) imaging to final treatment delivery. For tomotherapy treatment planning, a CT image set of the whole body was required. The patients were scanned in a large bore (75 cm) CT scanner (Siemens, SOMATOM Definition, Dual source computed tomography system). Because most critical organs are located in the central part of the body, therefore two image sets were scanned with 2.5 mm and 5 mm for upper and lower part, respectively. The level at 15 cm above knee was used as a reference point to separate the upper and lower set. The geometric edges of both fields were abutted at the HT treatment's 50% isodose plane.
Both image sets were restored on a Pinnacle workstation using the Pinnacle Launch Pad Restore utility then using the Philips Pinnacle3 treatment planning system for contouring because the HT planning system has no such capability. After that, the plan was transferred to the Tomotherapy Hi Art Planning system (Tomotherapy, Inc., Madison, Wisconsin, USA). The clinical target volume (CTV) included the entire body surface system with subcutaneous 0.5 cm. To account for set-up variability and breathing motion, a planning target volume (PTV) was generated with a 0.5 cm margin The prescription dose was 75 cGy/fraction in 4 times/wk for total skin area and for tumor area. Total doses of 30 Gy to 95% of the PTV are delivered to the total skin area and tumor part, respectively. The normal tissue dose constraints utilized were based on the results of the survey of the clinical outcome of the target dose and dose limits to various organs at risk (OARs) such as the brain, optic chiasm, optic nerves, lenses, eyes, parotid glands, oral cavity, thyroid gland, bilateral lungs, esophagus, heart, liver, spleen, pancreases, kidneys, bowel, bladder, uterus and vagina. Maximum importance was given to target dose coverage. The constraints on dose and penalty were adjusted accordingly during optimization. The field width, pitch, and modulation factor (MF) used for the treatment planning optimization were 2.5, 0.287 cm, and 3.5, respectively. The dose volume histograms (DVHs) were calculated for the target and individual OARs. Toxicity of treatment was scored according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Image guidance:
Daily check of patient positioning was performed by the MVCT system integrated in the tomotherapy machine. Briefly, before every treatment, MVCT scans were taken in selected regions using the normal mode (4 mm slice thickness) of the body and fused with the treatment planning CT scan using bony anatomy and soft tissue images such as the lungs. Three sets of MVCT scan (scan 1, orbits to T4; scan 2, T10 to the ischial tuberosities; scan 3, 15 cm above knee to 15 cm below knee) were performed to the check the patient's whole body alignment. MVCT scans were obtained. Image fusions were evaluated by the attending physician and physicist. Any translational shifts suggested by the image fusion results were applied to the final patient setup before treatment delivery. The tolerance of setup error allowed only a 5-mm difference between the three scans in any of the three translation directions and 1° of difference in roll. Additional selected MVCT scans were performed after treatment to verify patient immobilization.
- Conditions
- T-cell Lymphoma
- Keywords
- Helical tomotherapy, total skin electron therapy, TSEB, irradiation 5.
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T-cell lymphoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin lesions size
Measured: every month from treatment up to half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell LymphomaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854112
- Sponsor's protocol ID
- FEMH No. 101115-E
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01854112
- Acronym / sponsor ID
- FEMH No. 101115-E
- Conditions
- T-cell Lymphoma
- Keywords
- Helical tomotherapy, total skin electron therapy, TSEB, irradiation 5.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2017 (estimated)
- First posted
- 15 May 2013 (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.
Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One the most widely used TSET techniques consists of six dual fields initially developed at Stanford University 2. Dosimetrically, TSET at energies of about 3-7 MeV at the surface of a standing patient may result in significant dose variations due to variable skin distance, self shielding, irradiated fields overlapping and patient motion. Deviations occur from the prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid, are revealed in the literature. To improve this condition, a selection of patients with advanced skin disease and regional extension could be cured by a combination of TSEB and photon beam irradiation.
Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length of up to 160 cm, continuously in a helical pattern without the need for field junction. Total marrow irradiation (TMI) via HT with low toxicities for bone marrow transplantation of Asia multiple myeloma patients could be feasible . A study of HT for total scalp irradiation has also shown that the employment of directional and complete blocking on the inner structures can effectively force the tangential delivery of the majority of beamlets to the PTV, which can limit the treatment depth.
Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSI technique to increase dose delivery and decrease toxicities could be a workable and feasible. Here, we applied TSI via HT (HITS) for a woman with T cell lymphoma failure by chemotherapy, topic UV irradiation and local radiotherapy (RT) in MMH to overcome the surface dose inhomogeneity by conventional RT. Additionally, we will compare the advantages and disadvantages between the plan of HT and conventional RT for TSI.
Detailed description
Helical tomotherapy planning
Patient will dress the diving suit (3 mm thick) to create bolus effect. AccuFix™ Cantilever Board™ with shoulder depression and thermoplastic fixation were used for head and shoulder immobilization. BlueBagTM immobilization system (Medical Intelligence) was used to fix main trunk and extremities. Both immobilization systems provide a consistent treatment position from the initial computed tomography (CT) scanning, pretreatment megavoltage CT (MVCT) imaging to final treatment delivery. For tomotherapy treatment planning, a CT image set of the whole body was required. The patients were scanned in a large bore (75 cm) CT scanner (Siemens, SOMATOM Definition, Dual source computed tomography system). Because most critical organs are located in the central part of the body, therefore two image sets were scanned with 2.5 mm and 5 mm for upper and lower part, respectively. The level at 15 cm above knee was used as a reference point to separate the upper and lower set. The geometric edges of both fields were abutted at the HT treatment's 50% isodose plane.
Both image sets were restored on a Pinnacle workstation using the Pinnacle Launch Pad Restore utility then using the Philips Pinnacle3 treatment planning system for contouring because the HT planning system has no such capability. After that, the plan was transferred to the Tomotherapy Hi Art Planning system (Tomotherapy, Inc., Madison, Wisconsin, USA). The clinical target volume (CTV) included the entire body surface system with subcutaneous 0.5 cm. To account for set-up variability and breathing motion, a planning target volume (PTV) was generated with a 0.5 cm margin The prescription dose was 75 cGy/fraction in 4 times/wk for total skin area and for tumor area. Total doses of 30 Gy to 95% of the PTV are delivered to the total skin area and tumor part, respectively. The normal tissue dose constraints utilized were based on the results of the survey of the clinical outcome of the target dose and dose limits to various organs at risk (OARs) such as the brain, optic chiasm, optic nerves, lenses, eyes, parotid glands, oral cavity, thyroid gland, bilateral lungs, esophagus, heart, liver, spleen, pancreases, kidneys, bowel, bladder, uterus and vagina. Maximum importance was given to target dose coverage. The constraints on dose and penalty were adjusted accordingly during optimization. The field width, pitch, and modulation factor (MF) used for the treatment planning optimization were 2.5, 0.287 cm, and 3.5, respectively. The dose volume histograms (DVHs) were calculated for the target and individual OARs. Toxicity of treatment was scored according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Image guidance:
Daily check of patient positioning was performed by the MVCT system integrated in the tomotherapy machine. Briefly, before every treatment, MVCT scans were taken in selected regions using the normal mode (4 mm slice thickness) of the body and fused with the treatment planning CT scan using bony anatomy and soft tissue images such as the lungs. Three sets of MVCT scan (scan 1, orbits to T4; scan 2, T10 to the ischial tuberosities; scan 3, 15 cm above knee to 15 cm below knee) were performed to the check the patient's whole body alignment. MVCT scans were obtained. Image fusions were evaluated by the attending physician and physicist. Any translational shifts suggested by the image fusion results were applied to the final patient setup before treatment delivery. The tolerance of setup error allowed only a 5-mm difference between the three scans in any of the three translation directions and 1° of difference in roll. Additional selected MVCT scans were performed after treatment to verify patient immobilization.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-cell lymphoma | – | – |
Who may qualify
- Ages
- 37 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- T-cell lymphoma
Key inclusion criteria (1 listed)
- T-cell lymphoma
Key exclusion criteria (1 listed)
- -
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
Skin lesions size
Time frame: every month from treatment up to half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of T-cell Lymphoma, run by Far Eastern Memorial Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Skin lesions size (time frame: every month from treatment up to half year). 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 6 Aug 2014.