Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer

Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer - Prophylactic cranial irradiation for ED-SCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001755

Enrollment

330

Registered

2009-03-05

Start date

2009-03-01

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

Extensive small-cell lung cancer patients with no brain metastasis who had a response to platinum-based first-line chemotherapy,

Interventions

Prophylactic cranial irradiation 25Gy (2.5 Gy X 10frs) No therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 years of age or older 2. PS(ECOG)0-2 3. Documented extensive smallcell lung cancer 4. Response after at least 2 cycles of initial platinum-based chemotherapy. 5. No brain metastasis detected by brain MRI before randomization 6. An interval of no more than 6 weeks between the start of the last cycle of chemotherapy and randomization 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous radiotherapy to the head and neck area overlapped with PCI field. 2. Another active cancer 3. Serious psychological and/or physiological complications 4. An expectant or lactating woman

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Incidence of brain metastasis, Time to brain metastasis, Progression free survival, Adverse events	—

Countries

Japan

Contacts

Public ContactToshiaki Takahashi

Shizuoka Cancer Center Division of Thoracic Oncology

t.takahashi@scchr.jp055-989-5222

Outcome results

None listed

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