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A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine if the addition of low-dose total body irradiation (TBI) to involved-field
radiotherapy improves the disease-free survival of patients with previously untreated,
stage I or II low-grade non-Hodgkin's lymphoma.

- Determine the response of patients treated with low-dose TBI.

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

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, stage (I vs II), performance status (0-1 vs 2), lactate dehydrogenase
elevation (yes vs no), histological subtype (small lymphocytic lymphoma vs
lymphoplasmacytoid lymphoma vs follicular lymphoma), and, for stage I patients, presence of
measurable mass (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo involved-field radiotherapy daily five days a week for 2.5-4
weeks.

- Arm II: Patients undergo low-dose total body irradiation (TBI) daily 5 days a week on
weeks 1 and 4. At 4 weeks after completion of TBI, patients undergo involved-field
radiotherapy as in arm I.

Quality of life is assessed before treatment, at 4 weeks after completion of involved-field
radiotherapy, every 6 months for 5 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 344 patients will be accrued for this study within 6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage I or II, low-grade, non-Hodgkin's lymphoma

- Follicular lymphoma grade I, II, or III

- Small lymphocytic lymphoma

- Lymphoplasmacytoid lymphoma

- Nodal marginal zone lymphoma

- Previously untreated disease

- At least 1 measurable or evaluable mass at least 1.1 cm (except for patients with
stage I disease where the entire mass was removed for diagnostic purposes) NOTE: A
new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 2,000/mm ^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
situ of the cervix

- No psychological, familial, sociological, or geographical condition that would
preclude study participation

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Pierre Richaud, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut BergoniƩ

Authority:

United States: Federal Government

Study ID:

EORTC-20971-22997

NCT ID:

NCT00014326

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • nodal marginal zone B-cell lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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