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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-20992 |
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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 tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.
Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.
Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks.
Quality of life is assessed at baseline, after the third chemotherapy course, 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 29-56 patients will be accrued for this study within 12-18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate | Drug | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)
Previously untreated NHL
At least 1 measurable lesion
Poor physiological status with at least 1 of the following:
No cerebral or meningeal involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Soubeyran, MD, PhD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Network Antwerpen Middelheim | Antwerp | 2020 | Belgium | |||
| Centre Hospitalier Universitaire Brugmann |
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| Brussels |
| B 1020 |
| Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| National Cancer Institute of Egypt | Cairo | Egypt |
| Centre D'Oncologie Du Pays-Basque | Bayonne | F-64100 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Hospitalier de Dax | Dax | 40107 | France |
| Hopital Robert Boulin | Libourne | 33500 | France |
| Polyclinique de Francheville | Périgueux | 24004 | France |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9700 RB | Netherlands |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | 3001-301 | Portugal |
| Hopitaux Universitaires de Geneve | Thonex-Geneve | CH-1226 | Switzerland |
| New Cross Hospital | Wolverhampton | England | WV10 0QP | United Kingdom |
| Dumfries Royal Infirmary | Dumfries | DG1 4AP | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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