LymphomaPhase 2/3NCT00060385
Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma
A Phase 2/3 study testing CHOP regimen, EPOCH regimen and cyclophosphamide in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- CHOP regimen, EPOCH regimen and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2003to Aug 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large B-cell* or peripheral T-cell non-Hodgkin's lymphoma by REAL/WHO classification, including the following:
- All morphological and clinical variants
- All Ann Arbor stages NOTE: *Presence of a small cell, indolent lymphoma component in the bone marrow biopsy is allowed
- No Burkitt-like lymphoma
- Previously untreated disease
- No cerebral or meningeal involvement
- At least 1 measurable target lesion at least 1.1 cm by the Cheson criteria
PATIENT CHARACTERISTICS:
Age
- 70 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3 (unless related to bone marrow infiltration)
Hepatic
- Bilirubin less than 1.8 mg/dL*
- AST or ALT less than 2.5 times upper limit of normal (ULN)*
- Alkaline phosphatase less than 4 times ULN* NOTE: *Values above these thresholds are allowed only if related to non-Hodgkin's lymphoma
Renal
- Creatinine clearance at least 50 mL/min
Cardiovascular
- LVEF at least 50%
Other
- HIV negative
- No history of concurrent severe disease that would preclude study treatment
- No other prior or concurrent malignancy except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid malignancy with no evidence of disease for at least 5 years prior to study entry
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent participation in another investigational drug study
- No other concurrent antineoplastic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's lymphoma that has not been previously treated.
Read the detailed description
OBJECTIVES:
- Compare the complete response rates in older patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without etoposide.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the freedom from progression in patients treated with these regimens.
- Determine the toxicity of CHOP plus etoposide in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cellular type (B-cell vs T-cell), initial stage of disease (I and II vs III and IV), WHO performance status (0-1 vs 2), and lactic dehydrogenase level (LDH) (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.
- Arm I (CHOP chemotherapy): Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients then undergo disease evaluation.
Patients with disease progression or no change in disease are removed from study. Patients with responsive stage I or II disease receive 1 additional course if they demonstrate all 3 of the following conditions (at baseline): no LDH elevation, WHO performance status of 0-1, and greatest single diameter of any tumor site less than 5 cm. Patients with responsive stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the following conditions (at baseline): LDH elevation, WHO performance status 2, and/or greatest single diameter of any tumor site at least 5 cm. Patients with responsive stage III or IV disease receive 3 additional courses.
After the completion of chemotherapy, patients with responsive stage I or II disease undergo involved field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with initial bulky stage III or IV disease may also undergo radiotherapy.
- Arm II (CHOP chemotherapy and etoposide): Patients receive CHOP chemotherapy as in arm I plus oral etoposide 2 or 3 times daily on days 1-10. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients receive additional courses as in arm I.
After the completion of chemotherapy, patients with responsive stage I or II disease or initial bulky stage III or IV disease undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, after course 3, at the end of chemotherapy, every 6 months for 3 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 686 patients (126 for phase II and 560 for phase III) will be accrued for this study within 5 years.
- Conditions
- Lymphoma
- Being tested
- CHOP regimen, EPOCH regimen, cyclophosphamide, doxorubicin hydrochloride, etoposide
- Keywords
- stage I adult T-cell leukemia/lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II adult T-cell leukemia/lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP regimenDrug
EPOCH regimenDrug
cyclophosphamideDrug
etoposideDrug
prednisoneDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startMar 2003
- Primary completionAug 2004
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Soubeyran, MD, PhD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060385
- Sponsor's protocol ID
- EORTC-20991
- Other IDs
- EORTC-20991
- Status last verified
- Sep 2012
- First submitted
- 6 May 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life
- ClinicalTrials.gov ID
- NCT00060385
- Acronym / sponsor ID
- EORTC-20991
- Conditions
- Lymphoma
- Keywords
- stage I adult T-cell leukemia/lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II adult T-cell leukemia/lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Mar 2003
- Primary completion
- Aug 2004 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's lymphoma that has not been previously treated.
Detailed description
OBJECTIVES:
- Compare the complete response rates in older patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without etoposide.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the freedom from progression in patients treated with these regimens.
- Determine the toxicity of CHOP plus etoposide in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cellular type (B-cell vs T-cell), initial stage of disease (I and II vs III and IV), WHO performance status (0-1 vs 2), and lactic dehydrogenase level (LDH) (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.
- Arm I (CHOP chemotherapy): Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients then undergo disease evaluation.
Patients with disease progression or no change in disease are removed from study. Patients with responsive stage I or II disease receive 1 additional course if they demonstrate all 3 of the following conditions (at baseline): no LDH elevation, WHO performance status of 0-1, and greatest single diameter of any tumor site less than 5 cm. Patients with responsive stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the following conditions (at baseline): LDH elevation, WHO performance status 2, and/or greatest single diameter of any tumor site at least 5 cm. Patients with responsive stage III or IV disease receive 3 additional courses.
After the completion of chemotherapy, patients with responsive stage I or II disease undergo involved field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with initial bulky stage III or IV disease may also undergo radiotherapy.
- Arm II (CHOP chemotherapy and etoposide): Patients receive CHOP chemotherapy as in arm I plus oral etoposide 2 or 3 times daily on days 1-10. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients receive additional courses as in arm I.
After the completion of chemotherapy, patients with responsive stage I or II disease or initial bulky stage III or IV disease undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, after course 3, at the end of chemotherapy, every 6 months for 3 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 686 patients (126 for phase II and 560 for phase III) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOP regimen | Drug | – |
| EPOCH regimen | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| prednisone | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Soubeyran, MD, PhD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CHOP regimen, EPOCH regimen and cyclophosphamide in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.