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)

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) - A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for astrocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000108

Enrollment

310

Registered

2005-09-02

Start date

2004-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

astrocytoma grade 3/4

Interventions

A: RT+ACNU B: RT+Procarbazine+ACNU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven astrocytoma grade 3 or 4 2. Supratentorial tumor on preoperative MRI 3. No tumor recognized in the optic nerve, olfactory nerve and pituitary gland on preoperative MRI 4. No multiple legions or dissemination recognized on preoperative MRI 5. Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume 6. Three to 14 days after surgery for astrocytoma (removal or biopsy) 7. Age 20-69 y.o. 8. ECOG performance status (PS) 0,1,2 or 3 due to neurological signs caused by the tumor 9. Initial treatment for astrocytoma grade 3 or 4 10. No prior radiotherapy or chemotherapy for cancers including other organs 11. Lab data as follows WBC >= 3,000/mm3 Hemogllobin >= 8.0g/dl Platelet >= 100,000/mm3 creatinine <= 1.5mg/dl GOT <= 100 IU GPT <= 100 IU 12. Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Endpoint in phase II stage: 6 months survival Endpoint in phase III stage: Overall survival (OS)	—

Secondary

Measure	Time frame
Endpoint in phase II stage: Overall survival (OS) Endpoint in phase III stage: Progression free survival (PFS) ,Response rate (RR), % complete response (%CR),Toxicity	—

Countries

Japan

Contacts

Public ContactSoichiro Shibui, MD, DMSc

JCOG0305 Coordinating Office Neurosurgery Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026