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Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005584
First Posted: January 27, 2003
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lymphoma Study Association
UNICANCER
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
May 2, 2000
January 27, 2003
July 27, 2017
October 1998
May 2004   (Final data collection date for primary outcome measure)
Relapse-free rate [ Time Frame: 5 years ]
with events defined as lack of CR/CRu at the end of treatment or relapse
Not Provided
Complete list of historical versions of study NCT00005584 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Till withdrawal criteria met ]
  • Failure Free Survival [ Time Frame: Till withdrawal criteria met ]
  • Relapse Free Survival [ Time Frame: Till withdrawal criteria met ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.

OBJECTIVES:

  • Compare the late toxicity of 6 courses of epirubicin, bleomycin, vinblastine, and prednisone (EBVP) followed by involved-field radiotherapy (IF-RT) (36 Gy) vs IF-RT (20 Gy), vs no IF-RT (closed to accrual as of 6/2002) in patients with supradiaphragmatic Hodgkin's lymphoma, favorable prognosis, and complete remission (CR) or CR unconfirmed after completion of chemotherapy. (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
  • Compare 6 courses of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs 4 courses of ABVD vs 4 courses of cyclophosphamide, doxorubicin, vincristine, bleomycin, etoposide, procarbazine, and prednisone (BEACOPP) followed by IF-RT, with respect to overall survival and late treatment-related toxicity, in patients with supradiaphragmatic Hodgkin's lymphoma and unfavorable prognosis. (Unfavorable prognosis group [group 2] closed to accrual as of 9/2002.) (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
  • Maintain the failure-free survival and relapse-free survival rates that were reached in the previous EORTC studies (H5 to H8), with a reduction in acute and delayed side effects of the treatment, in particular that of severe late radiotherapy and chemotherapy-related toxicity.
  • Compare the quality of life, overall survival, treatment quality control, and duration of treatment in patients with favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognoses treated with these regimens.
  • Determine the efficacy of conservative therapy comprised of observation until disease progression (DP) and administration of IF-RT at the time of DP in patients with lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma).

OUTLINE: This is a randomized, multicenter study.

Patients with classical Hodgkin's lymphoma are assigned to 1 of 2 randomized groups. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.) Patients with lymphocyte-predominant Hodgkin's lymphoma are assigned to the nonrandomized group.

Randomized groups

  • Patients are stratified by prognosis (favorable vs unfavorable). Patients are assigned to 1 of 2 treatment groups based on prognosis. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.)

    • Group 1 (favorable prognosis) (closed to accrual as of 4/28/04): Patients receive epirubicin IV over 5 minutes, bleomycin intramuscularly (IM) (or IV if necessary), and vinblastine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 6 courses. Patients are then assigned to 1 of 3 involved-field radiotherapy (IF-RT) groups based on response to chemotherapy:

      • Group A (complete remission (CR) or CR unconfirmed [CRu]) Patients are randomized to 1 of 3 radiotherapy arms. (Arm III closed to accrual as of 6/2002.)

        • Arm I (36 Gy): Patients undergo IF-RT 5 days a week for 3.5 weeks.
        • Arm II (20 Gy): Patients undergo IF-RT 5 days a week for 2 weeks.
        • Arm III (closed to accrual as of 6/2002): Patients undergo no IF-RT.
      • Group B (partial remission [PR]): Patients undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy.
      • Group C (stable disease or disease progression [DP]): Patients receive no IF-RT and are taken off study.
    • Group 2 (unfavorable prognosis) (closed to accrual as of 9/2002): Patients are randomized to 1 of 3 treatment arms.

      • Arm I: Patients receive doxorubicin IV over 5 minutes, bleomycin IM (or IV if necessary), vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses.
      • Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 4 weeks for 4 courses.
      • Arm III: Patients receive cyclophosphamide IV and doxorubicin IV over 5 minutes on day 1, vincristine IV and bleomycin IM (or IV if necessary) on day 8, etoposide IV over a minimum of 30 minutes on days 1-3, oral procarbazine on days 1-7, and oral prednisone on days 1-14. Treatment repeats every 3 weeks for 4 courses.

Patients on all arms who achieve CR or CRu undergo IF-RT 5 days a week for 3 weeks. Patients who achieve PR undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy.

  • Groups 1 and 2 (group 2 closed to accrual as of 9/2002) (group 1 closed to accrual as of 4/28/04): IF-RT begins within 3-4 weeks after completion of the last course of chemotherapy.

Nonrandomized group

  • Patients with completely resected stage I disease undergo observation until DP and undergo IF-RT after documentation of DP. Patients with stage II or incompletely resected stage I disease undergo IF-RT immediately.

Quality of life is assessed before starting study therapy, immediately after completion of study, and then annually for 10 years.

Patients are followed at 2, 4, 6, 9, and 12 months; every 4 months for 1 year; every 6 months for 3 years; and then annually thereafter.

PROJECTED ACCRUAL: A total of 903 patients (group 1) will be accrued for this study within 7.7 years. A total of 723 patients (group 2) will be accrued for this study within 3.8 years. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.)

Interventional
Phase 3
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
  • Biological: bleomycin sulfate
  • Drug: ABVD regimen
  • Drug: BEACOPP regimen
  • Drug: epirubicin hydrochloride
  • Drug: prednisone
  • Drug: vinblastine sulfate
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1649
Not Provided
May 2004   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma

    • No prior staging laparotomy
    • Favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognosis
  • Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma)

    • Stage I with complete or incomplete resection OR
    • Stage II

PATIENT CHARACTERISTICS:

Age:

  • 15 to 70

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No severe cardiac disease that would interfere with normal life expectancy or study treatment

Pulmonary:

  • No severe pulmonary disease that would interfere with normal life expectancy or study treatment

Other:

  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No severe neurologic or metabolic disease that would interfere with normal life expectancy or study treatment
  • No psychologic, familial, socioeconomic, or geographic circumstances that would preclude proper staging or compliance
  • HIV negative
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this malignancy

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • No prior endocrine therapy for this malignancy

Radiotherapy

  • No prior radiotherapy for this malignancy

Surgery

  • No prior surgery for this malignancy
Sexes Eligible for Study: All
15 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Italy,   Netherlands,   Poland,   Portugal,   Slovakia,   Slovenia,   Spain,   Switzerland
 
 
NCT00005584
EORTC-20982
FRE-FNCLCC-98014 ( Other Identifier: FRE-FNCLCC )
GELA-H9 ( Other Identifier: GELA )
Not Provided
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
  • Lymphoma Study Association
  • UNICANCER
Study Chair: Jose Thomas, MD University Hospital, Gasthuisberg
Study Chair: H. Eghbali, MD Institut Bergonié
Study Chair: E.M. Noordijk, MD Leiden University Medical Center
Study Chair: Christophe Ferme Centre Medical de Bligny
Study Chair: Christian Gisselbrecht, MD Hopital Saint-Louis
Study Chair: Thierry O. Philip, MD Centre Leon Berard
European Organisation for Research and Treatment of Cancer - EORTC
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP