UMIN ID: C000000108
Registered date:02/09/2005
A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for strocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | astrocytoma grade 3/4 |
| Date of first enrollment | 2004/06/01 |
| Target sample size | 310 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: RT+ACNU B: RT+Procarbazine+ACNU |
Outcome(s)
| Primary Outcome | Endpoint in phase II stage: 6 months survival Endpoint in phase III stage: Overall survival (OS) |
|---|---|
| Secondary Outcome | Endpoint in phase II stage: Overall survival (OS) Endpoint in phase III stage: Progression free survival (PFS) ,Response rate (RR), % complete response (%CR),Toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 69years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Synchronous double cancer or metachronous double cancer in last 5 years; carcinoma in situ accepted 2. Meningitis or pneumonia 3. Pregnant, possibly pregnant or nursing women 4. Mental disorder 5. Uncontrollable diabetes mellitus or DM under treatment with Insulin 6. Myocardial infarction in last 3 months 7. History of pulmonary fibrosis or interstitial pneumonia |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Soichiro Shibui, MD, DMSc |
| Address | 5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0305 Coordinating Office Neurosurgery Division, National Cancer Center Hospital |
| scientific contact | |
| Name | Soichiro Shibui, MD, DMSc |
| Address | 5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital Neurosurgery Division |