Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma

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Brief Title

Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma


Brief 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. 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 Type

Observational


Primary Outcome

Skin lesions size


Condition

T-cell Lymphoma


Study Arms / Comparison Groups

 T-cell lymphoma
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1

Start Date

November 2012


Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

        T-cell lymphoma

        Exclusion Criteria:

        -
      

Gender

Female

Ages

37 Years - 37 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT01854112

Organization ID

FEMH No. 101115-E


Responsible Party

Sponsor

Study Sponsor

Far Eastern Memorial Hospital


Study Sponsor

, , 


Verification Date

May 2013