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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 47 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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News


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1. Overview



Summary

Chlorambucil versus 2 x 2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. A prospective, randomized phase III clinical trial.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

300


Date of activation

04-Oct-2001


Approved by

CKTO: CKVO 2001 -01
MEC: PTC The Netherlands Cancer Institute 25-04-2001


Study objectives

To assess the effect of 2 x 2 Gy involved field radiotherapy compared with Chlorambucil with respect to progression free survival (PFS) and quality of life.
As secondary objectives the effect of 2 x 2 Gy involved field radiotherapy will be evaluated as regards complete remission rate, partial remission rate, overall survival, toxicity and compared to Chlorambucil.


2. Patient eligibility criteria



Inclusion criteria

Previously untreated Ann Arbor stage III and IV follicular lymphoma patients, grade I – III. (see appendices A and C)
Age 65 years or more, no upper limit.
WHO Performance Status 0 - 2. (see appendix E)
Nodal and extranodal sites, measurable bidimensionally on physical examination or diagnostic imaging.
Adequate haematological parameters at diagnosis: Hb >= 6.0 mmol/l, leukocytes >= 4.0 x 109 /l, thrombocytes >= 100 x 109 /l.
Written informed consent.


Exclusion criteria

Severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease precluding either Chlorambucil chemotherapy or radiotherapy.
Patients with prior malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Patients unable to fulfil regular outpatient appointments both for treatment and follow-up.
Known HIV-positivity.
Known central nervous system or orbital NHL localisation.
Use of systemic corticosteroid medication (inhalation and topical corticosteroids are allowed).


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:



Protocol number
Institution name
Name of caller/responsible investigator
Patient’s initials or code
Patient’s hospital record number
Sex
Date of birth
Date of diagnosis of follicular lymphoma
PA number
Eligibility criteria.


4. Participating parties



Principal investigator

R.L.M. Haas (rhaas@nki.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

C. van Hooije (c.vanhooije@erasmusmc.nl)


Central data management

C. van Hooije (c.vanhooije@erasmusmc.nl)


Other functions

Central Pathologist:
D. de Jong (djong@nki.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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