NCT00841945终止3 期
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
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Event Free Survival (EFS) and Progression Free Survival (PFS)
研究概览
简要总结
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.
详细描述
CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.
Interest of the radiotheraphy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Active Comparator
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
干预措施: rituximab (Drug)
1
Active Comparator
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
干预措施: doxorubicin (Drug)
1
Active Comparator
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
干预措施: vincristine (Drug)
1
Active Comparator
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
干预措施: prednisone (Drug)
1
Active Comparator
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
干预措施: radiotherapy (Procedure)
2
Experimental
Chemotherapy
- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
干预措施: rituximab (Drug)
2
Experimental
Chemotherapy
- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
干预措施: doxorubicin (Drug)
2
Experimental
Chemotherapy
- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
干预措施: vincristine (Drug)
2
Experimental
Chemotherapy
- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
干预措施: prednisone (Drug)
结局指标
主要结局
Event Free Survival (EFS) and Progression Free Survival (PFS)
时间窗: EFS PFS one year after treatment
次要结局
- Pet-scan(pronostic impact of Pet-scan)
- radiotherapy(Toxicity of the radiotherapy)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the BodyClinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Metastatic Esophageal AdenocarcinomaMetastatic Gastric AdenocarcinomaOligometastatic Esophageal AdenocarcinomaOligometastatic Gastric AdenocarcinomaPathologic Stage IV Esophageal Adenocarcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8NCT04248452ECOG-ACRIN Cancer Research Group314
招募中
不适用
Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLCRadiotherapyNon Small Cell Lung CancerStage IV Non-small Cell Lung CancerQuality of LifeNCT04530708Swedish Lung Cancer Study Group162
进行中（未招募）
3 期
Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)HNSCCNCT02998385Groupe Oncologie Radiotherapie Tete et Cou342
招募中
3 期
Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by SurgeryNCT03180268NRG Oncology163
已完成
3 期
Randomized Trial of ARCON in Larynx CancerLarynx CarcinomaNCT00147732Radboud University Medical Center345