Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Ly… (NCT00003389) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
United States, Canada, South Africa854 participantsStarted 1999-06-17
Plain-language summary
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 more than one drug 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: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Histologically proven previously untreated classical Hodgkin's lymphoma
* The following stages are eligible:
* Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy
* Advanced: Stage III or IV
* Measurable or evaluable disease
* Age of 16 and over
* ECOG Performance status 0-2
* Disease-free of prior invasive malignancies for \>5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)
* Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)
* Bilirubin no greater than 5.0 mg/dL
* Creatinine no greater than 2.0 mg/dL
* Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease
* Fertile patients must use effective contraception
* Prior corticosteroids allowed
* Prior surgery allowed
Exclusion criteria:
* Pregnant or nursing
* Prior radiotherapy
* Prior chemotherapy
* Human immunodeficiency virus (HIV) positive
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Failure-free Survival at 5 Years
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5