The University of Southampton
Southampton Clinical Trials Unit

IELSG - 37 Trial

Trial started November 2013

Senior Trial Manager: Kelly Cozens

Trial Manager: Carol Tyas

 

Trial legal documents

IELSG - 37 - Site Delegation Log v1.0 19-02-13.pdf

IELSG - 37 - Rec approval _SA1. 19-05-14.pdf

IELSG 37 Radiation Compliance Form v3.0 08022016

IELSG 37 - 13 SC 0317 Favourable Substantial Amendment - 2 18-02-16

IELSG 37 - Consent Form v4 03-02-16

IELSG 37 - GP Letter v2.0 03-02-16

IELSG 37 - Patient Information Sheet v4.0 03-02-16

IELSG 37 - Protocol v3.0 08-02-16

IELSG 37 - Study Ack v3.0 08-02-16

 

Patient documents

IELSG - 37 - Patient Screening and Recruitment Log v2.0 02-10-13.doc

 

CRF documents

 

IELSG 37 - Widen RT Case Submission Guidelines

IELSG 37 eCRFs v2.0 140414

Trial status

Open to recruitment

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IELSG 37

Description

This is a randomised trial designed to see whether observation is comparable to radiotherapy treatment after chemotherapy+rituximab for Primary Mediastinal B-Cell Lymphoma in relation to progression and long term safety. Patients will receive a PET scan pre & post R-chemotherapy.
Those who are PET negative will be randomised to receive RT or observation.

Objectives

To evaluate the possibility to spare the radiotherapy in PMBCL patients, who have become ‘PET-negative’ after a combined R-chemotherapy.

Population

This is an international trial looking to recruit at least 540 patients.

Considerations

Details to follow.

Duration

All randomised patients will be followed up for 10 years.

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