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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 25 NHL / OG 95-004


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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News


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1. Overview



Summary

Effect of Recombinant G-CSF on the Results of Chemotherapy (CHOP) in Elderly Patients with Intermediate-/High-Grade Non-Hodgkin's Lymphoma: A Prospective Phase III Study.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

375


Date of activation

01-Aug-1994


Approved by

Dutch Cancer Foundation: CKVO 94-01
National Health Council of the Netherlands: OG 95-004


2. Patient eligibility criteria



Inclusion criteria

Patients with previously untreated Non-Hodgkin�s Lymphoma, Ann Arbor stages II-IV, of intermediate- or high-grade malignancy.
Patients with age 65 years or more.
Informed consent.


Exclusion criteria

Patients aged less than 65
Patients who have been treated for Non-Hodgkin�s Lymphoma by chemotherapy or radiotherapy.
Other malignant diseases, except localized squamous skin carcinoma.
Severe heart failure.
Inadequate liver or renal function.
Failure to give informed consent.
HIV positivity.


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 and/or physician in charge
Hospital record number
Patient name, date of birth and sex
Pathology diagnosis
Stage II, III or IV, A/B
Serum LDH


4. Participating parties



Principal investigator

P Sonneveld (sonneveld@haed.azr.nl)


Coordinating investigator(s)

JK Doorduijn (jdoorduyn@haed.azr.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)
B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

MMC Steijaert (steijaert@stah.azr.nl)


Central data management

MMC Steijaert (steijaert@stah.azr.nl)


Other functions

Cost-Effectiveness Analysis:
FFH Rutten
C Uyl
Central Pathologist:
AH Mulder (amulder@rijnstate.nl)

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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