A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.

A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer. - A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000214

Enrollment

Registered

2005-09-13

Start date

2001-07-01

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

Small-cell lung cacer, limited disease

Interventions

Cisplatin + etoposide with conccrent accelerated hyperfractionated thoracic radiation therapy followed by high-dose chemotherapy (ifosfamide/carboplatin/etoposide) with autologous peripheral blood st

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically documented SCLC 2. No prior therapy 3. 65 years old or less 4. Performance status (ECOG) of 0 - 2 5. Normal hematologic function: WBC>=4000/microml, PLT>=100,000/microml 6. Normal hepatic function: T-Bil==60% 9. Normal cardiac function: Ejection fraction=>60% 10. Written informed consent Eligibility Criteria for High-Dose Chemotherapy 1. Responders to the induction chemotherapy: CR or PR 2. Performance status (ECOG) of 0 - 1 3. Normal hematologic, hepatic, renal, pulmonary and cardiac functions 4. PBSCs CD34 positive cells=>1x10^6/kg

Exclusion criteria

Exclusion criteria: Patients who had tumors involvement in the bone marrow or brain, active double cancers or serious underlying disease (interstitial pneumonia, serious cardiac diseases, uncontrolled diabetes mellitus, serious infection, carrier of HBV, HCV,or HIV) are excluded.

Design outcomes

Primary

Measure	Time frame
5-year disease free survival	—

Countries

Japan

Contacts

Public ContactKatsuyuki Kiura, M.D. Ph.D.

Okayama University Graduate School of Medicine, Dentistry, and Phamaceutical Science Department of Hematology, Oncology, and Respiratory Midicine

kkiura@md.okayam-u.ac.jp086-235-7225

Outcome results

None listed

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