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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 26 NHL


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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1. Overview



Summary

Intensified CHOP of 12-Weeks Duration plus G-CSF as compared with Standard CHOP of 24-Weeks Duration for Patients with Intermediate-Prognosis Non-Hodgkin�s Lymphoma.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

375


Date of activation

15-Nov-1994


Approved by

CKVO 94-08


2. Patient eligibility criteria



Inclusion criteria

Previously untreated patients with a primary NHL of intermediate- or high-grade malignancy according to the Working Formulation. The lymphoblastic lymphomas are excluded.
Belonging to the intermediate-risk group.


Exclusion criteria

Patients with NHL of intermediate- or high-grade malignancy but with: - ages < 15 years and > 65 years. - belonging to the low- or high-risk group.
Patients with prior malignancies, except stage I cervix carcinoma and basocellular carcinoma.
Patients with severe cardiac, pulmonary, neurologic or metabolic disease.
Inadequate liver or renal function.
HIV positivity.
Inability to give informed consent.
Involvement of the central nervous system.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Name institute
Name of caller/physician who treats the patient
Name or initials of patient
Hospital record number
Sex
Date of birth
Diagnosis
Stage
LDH


4. Participating parties



Principal investigator

LF Verdonck (l.f.verdonck@digd.azu.nl)


Coordinating investigator(s)

GW van Imhoff (g.w.imhoff@int.azg.nl)


Trial manager

I Meulendijks (l.meulendijks@eramusmc.nl)


Central data management

M.C.J. Testroote (m.testroote@erasmusmc.nl)


Other functions

Statisticians:
WJ Graveland (graveland@stah.azr.nl)
Central Pathologist:
JG van den Tweel (j.vandentweel@lab.azu.nl)

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
28
NL-Alkmaar-Noordwest Ziekenhuisgroep
1
NL-Amersfoort-Meander MC
26
NL-Amstelveen-Ziekenhuis Amstelland
0
NL-Amsterdam-AMC
18
NL-Amsterdam-Antoni van Leeuwenhoek ZH
9
NL-Amsterdam-OLVG
2
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
5
NL-Amsterdam-Slotervaart Ziekenhuis
3
NL-Amsterdam-VUMC
26
Show 61 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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