NCT01854112

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

August 6, 2014

Status Verified

May 1, 2013

Enrollment Period

5.1 years

First QC Date

May 9, 2013

Last Update Submit

August 5, 2014

Conditions

Keywords

Helical tomotherapytotal skin electron therapyTSEBirradiation 5.

Outcome Measures

Primary Outcomes (1)

  • Skin lesions size

    every month from treatment up to half year

Study Arms (1)

T-cell lymphoma

Eligibility Criteria

Age37 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

T-cell lymphoma

You may qualify if:

  • T-cell lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 15, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2017

Last Updated

August 6, 2014

Record last verified: 2013-05