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A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018) - A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005993
Enrollment
110
Registered
2011-07-18
Start date
2011-07-01
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

Non-small cell lung cancer

Interventions

cisplatin+TS-1+thoracic radiotherapy cisplatin+docetaxel+thoracic radiotherapy

Sponsors

Thoracic Oncology Research Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed NSCLC 2)stage III NSCLC with no prior chemotherapy, radiotherapy or surgery (open biopsy is allowed) 3)unresectable lung cancer 4)V20 <=95% or equivalent dose to it 5)oral intake is possible 6)aged 20 years or older, under 75 years 7)ECOG PS 0-1 8)adequate organ function -WBC count >=4000/mm3 -neutrophil count >=2000/mm3 -hemoglobin >=9.5g/dL -platelet count >=100000/mm3 -AST and ALT <=100IU/L -total bilirubine level <=1.5mg/dL -serum creatinine <=1.5mg/dL -creatinine clearance >=60mL/min -PaO2 >=70torr 9)written informed consent

Exclusion criteria

Exclusion criteria: 1)T3N1 2)SVC syndrome with difficulty of a lot of intravenous infusion 3)clinically significant contralateral hilar lymph node metastasis, carcinomatous pericardial or pleural effusion, or carcinomatous lymphangitis 4)concurent serious infection or complications 5)continuous watery diarrhea 6)significant interstitial pneumonitis or pulmonary fibrosis in chest CT 7)concomitant cancers within 5 years 8)concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine 9)inadequately controlled diabetes mellitus 10)HBs Ag is positive 11)a history of serious drug allergy 12)mental disease or psychotic manifestation 13)pregnancy, breast feeding, wish of future bearing or hesitation in contraception 14)other conditions not suitable for this study

Design outcomes

Primary

MeasureTime frame
2 year survival rate

Secondary

MeasureTime frame
over all survival, progression free survival, adverse events, dose intensity

Countries

Japan

Contacts

Public ContactTsuneo Shimokawa

Yokohama Municipal Citizen's Hospital Department of Respiratory Medicine

ts00-shimokawa@city.yokohama.jp

Outcome results

None listed

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