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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT01854112
Study groupRoleWhat they receive
T-cell lymphomaNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 May 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2017 (estimated)

Resources

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)
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

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.

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