Main info

Identifier:

HOVON 47 NHL

Sponsor:

HOVON

Included patients:

15

Active sites:

0

(of 13)

Title:

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.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

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).