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NCT00379041Active, not recruitingPhase 3

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

Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]

Source: ClinicalTrials.gov · Last updated 5 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1158 (estimated)
First submitted
20 Sept 2006
Start date
1 Sept 1993
Primary completion date
1 Oct 1998
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
NCT number
NCT00379041

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1158
  • From 1 Sept 1993 to the primary completion date, 1 Oct 1998
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed supradiaphragmatic Hodgkin's lymphoma
    • Stage I or II disease
  • Previously untreated disease
    • PATIENT CHARACTERISTICS:
  • WHO performance status 0-2
  • Normal life expectancy
  • No severe cardiac, pulmonary, neurologic, or metabolic disease that would interfere with normal life expectancy or study treatment
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, socioeconomic, or geographic circumstance that would preclude proper staging or study compliance
  • HIV negative
  • Not pregnant
  • Fertile patients must use effective contraception
    • PRIOR CONCURRENT THERAPY:
  • No prior staging laparotomy
  • No prior biologic therapy, chemotherapy, endocrine therapy, radiotherapy, or surgery for this malignancy

Age in the registry: 15 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.