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Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life


Phase 2/Phase 3
70 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life


OBJECTIVES:

- Compare the complete response rates in older patients with diffuse large B-cell or
peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) with vs without etoposide.

- Compare the overall survival of patients treated with these regimens.

- Compare the time to treatment failure in patients treated with these regimens.

- Compare the freedom from progression in patients treated with these regimens.

- Determine the toxicity of CHOP plus etoposide in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
cellular type (B-cell vs T-cell), initial stage of disease (I and II vs III and IV), WHO
performance status (0-1 vs 2), and lactic dehydrogenase level (LDH) (normal vs abnormal).
Patients are randomized to 1 of 2 treatment arms.

- Arm I (CHOP chemotherapy): Patients receive cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment
repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients
then undergo disease evaluation.

Patients with disease progression or no change in disease are removed from study. Patients
with responsive stage I or II disease receive 1 additional course if they demonstrate all 3
of the following conditions (at baseline): no LDH elevation, WHO performance status of 0-1,
and greatest single diameter of any tumor site less than 5 cm. Patients with responsive
stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the
following conditions (at baseline): LDH elevation, WHO performance status 2, and/or greatest
single diameter of any tumor site at least 5 cm. Patients with responsive stage III or IV
disease receive 3 additional courses.

After the completion of chemotherapy, patients with responsive stage I or II disease undergo
involved field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with initial
bulky stage III or IV disease may also undergo radiotherapy.

- Arm II (CHOP chemotherapy and etoposide): Patients receive CHOP chemotherapy as in arm
I plus oral etoposide 2 or 3 times daily on days 1-10. Treatment repeats every 21 days
for 3 courses in the absence of unacceptable toxicity. Patients receive additional
courses as in arm I.

After the completion of chemotherapy, patients with responsive stage I or II disease or
initial bulky stage III or IV disease undergo radiotherapy as in arm I.

Quality of life is assessed at baseline, after course 3, at the end of chemotherapy, every 6
months for 3 years, and then annually thereafter.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 686 patients (126 for phase II and 560 for phase III) will be
accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of diffuse large B-cell* or peripheral T-cell non-Hodgkin's lymphoma by
REAL/WHO classification, including the following:

- All morphological and clinical variants

- All Ann Arbor stages NOTE: *Presence of a small cell, indolent lymphoma
component in the bone marrow biopsy is allowed

- No Burkitt-like lymphoma

- Previously untreated disease

- No cerebral or meningeal involvement

- At least 1 measurable target lesion at least 1.1 cm by the Cheson criteria

PATIENT CHARACTERISTICS:

Age

- 70 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3 (unless related to bone marrow infiltration)

Hepatic

- Bilirubin less than 1.8 mg/dL*

- AST or ALT less than 2.5 times upper limit of normal (ULN)*

- Alkaline phosphatase less than 4 times ULN* NOTE: *Values above these thresholds are
allowed only if related to non-Hodgkin's lymphoma

Renal

- Creatinine clearance at least 50 mL/min

Cardiovascular

- LVEF at least 50%

Other

- HIV negative

- No history of concurrent severe disease that would preclude study treatment

- No other prior or concurrent malignancy except adequately treated basal cell skin
cancer, curatively treated carcinoma in situ of the cervix, or other curatively
treated solid malignancy with no evidence of disease for at least 5 years prior to
study entry

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No concurrent participation in another investigational drug study

- No other concurrent antineoplastic agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Pierre Soubeyran, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut BergoniƩ

Authority:

United States: Federal Government

Study ID:

EORTC-20991

NCT ID:

NCT00060385

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell

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