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Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    3 amendments

    3 re-verifications since 2023-02-14, no change to tracked fields

    v20-v22

  2. Minor

    Primary completion date: Oct 1998 to Oct 1, 1998

    Start date: Sep 1993 to Sep 1, 1993

    Study Statusv19

  3. Minor

    2 amendments

    2 re-verifications since 2016-10-25, no change to tracked fields

    v17-v18

  4. Minor

    Primary completion date: Oct 1998

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv16

  5. Minor

    Interventions: bleomycin sulfate (Biological), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine… to bleomycin sulfate (Biological), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine…

    Study Status, Arms and Interventionsv15

Show 13 earlier versions

  1. Minor

    Publications: details revised at 1 of 3 entries

    Study Status, Referencesv14

  2. Minor

    Interventions: bleomycin (Biological), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine… to bleomycin sulfate (Biological), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine…

    Study Status, Arms and Interventionsv13

  3. Minor

    Interventions: bleomycin (Drug), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine hydrochloride… to bleomycin (Biological), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine…

    Study Status, Arms and Interventionsv12

  4. Minor

    Interventions: bleomycin (Drug), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine hydrochloride… to bleomycin (Drug), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine hydrochloride…

    Study Status, Arms and Interventionsv11

  5. Minor

    Publications: 2 to 3

    Show what changed: Publications
    Mounier N, Heutte N, Flechtner H, et al.: Quality of life in early stage Hodgkin lymphoma (HL) patients from the EORTC-GELA H8 Trial (20931): A post-treatment longitudinal study of 1,015 patients. [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.

    Study Status, Referencesv10

  6. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v9

  7. Minor

    Interventions: bleomycin (Drug), chemotherapy (Procedure), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug)… to bleomycin (Drug), doxorubicin hydrochloride (Drug), mechlorethamine hydrochloride (Drug), prednisone (Drug), procarbazine hydrochloride…

    Study Status, Arms and Interventionsv8

  8. Minor

    2 amendments

    2 re-verifications since 2007-12-15, no change to tracked fields

    v6-v7

  9. Minor

    Publications: details revised at 1 of 2 entries

    Study Status, Referencesv5

  10. Minor

    2 amendments

    2 re-verifications since 2007-09-18, no change to tracked fields

    v3-v4

  11. Minor

    Enrollment target: 1158

    Start date: Sep 1993; Study description expanded, about 8 words

    Show what changed: Study description
    [...] ntle field radiotherapy 5 days a week for at least 4 weeks. Stratum 2 (favorable prognosis): Patients are randomized to 1 of 2 treatment arms. Arm I: Pat [...] lved field radiotherapy 5 days a week for at least 4 weeks. Stratum 3 (unfavorable prognosis): Patients are randomized to 1 of 3 treatment arms. Arm I: Pat [...]

    Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.
Trial Details
NCT Number NCT00379041
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions Lymphoma
Enrollment 1,158 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov