NCT00496743

Brief Summary

The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of stage IB-II mycosis fungoides.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
Last Updated

July 4, 2007

Status Verified

July 1, 2007

First QC Date

July 2, 2007

Last Update Submit

July 2, 2007

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (2)

  • Response rates

  • Duration of responses

Interventions

Low-dose total skin electron beam therapy (4 Gy)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed mycosis fungoides stage I-II with failure to obtain full remission after standard PUVA treatment or relapse within 4 months of PUVA treatment

You may not qualify if:

  • under 18 years, pregnancy, other somatic diseases with a life expentancy under 1/2 years, psycological disorder preventing the patient to understand the information and cooperate in the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycosis Fungoides

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Gniadecki, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 4, 2007

Study Start

January 1, 2002

Study Completion

January 1, 2006

Last Updated

July 4, 2007

Record last verified: 2007-07