Clinical trial · Interventional
Treatment of Aggressive Localized Lymphoma
Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma
NCT00841945CI-TRIAL-00026099terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): other drugs other studies
Summary
Brief summary (as posted)
Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin | Drug | Doxorubicin | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| radiotherapy | Procedure | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Chemotherapy + Radiotherapy \- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone * Radiotherapy 40 gray on initial nodes
- interventionNames
- Drug: rituximab
- Drug: doxorubicin
- Drug: vincristine
- Drug: prednisone
- Procedure: radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- Chemotherapy \- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
- interventionNames
- Drug: rituximab
- Drug: doxorubicin
- Drug: vincristine
- Drug: prednisone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 and \< 75 years * Diffuse B large cell lymphoma , CD 20+ * Ann Arbor stage I or II withe a bulk \<7 cm * stage i ou II confirmed by the PET-scan * No previously treated * HIV negative * Signed Informed consent Exclusion Criteria: * Age\< 18 and \> 75 years * other type of lymphoma * CD20 negative * Ann Arbor stage \>II or bulk \> 7 cm * HIV positive * Contraindication to Rituximab use according to Sm PC * Containdication to antracyclin * cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma * Refusal of sign the informed consent
References
Publications (2)
- DERIVEDLamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Bene MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23. PMID 29061568
- DERIVEDTout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1. PMID 28251914