Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)

Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study) - Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005380

Enrollment

Registered

2011-04-10

Start date

2011-04-01

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

Induction chemoradiotherapy TS-1+CBDCA+RT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-small-cell lung cancer 2) Stage 2(except N0) or stage 3 3)No previous therapy 4)Performance status was 0 to 2 5)No distant metastasis were revealed by FDG-PET (chest CT, abdominal CT, brain CT, MRI, bone scan) 6)Adequate function of vital organs, including normal hematopoietic function, normal liver function, normal renal function and normal lung function as evidenced by the following data: 1:WBC >= 4,000/mm3, < 12,000/mm3 2:Neu >= 1,500/ mm3 3:Plt >= 100,000/ mm3 4:Hb >= 9.0g/dl 5:T-Bil < 1.5mg/dL 6:AST and ALT, x 2.5 of upper limit of normal (ULN) or less 7:creatinine clearance>=60ml/min 8:PaO2 >= 60 torr or SpO2 >= 90% 7) Normal Cardiac function 8)Written informed consent by the patient

Exclusion criteria

Exclusion criteria: 1)Patient who is not candidates for Carboplatin or TS-1 2)Patient with Anamnesis of drug allergy 3)Patient with Myocardial infarction within the past 6 months 4)Patient with Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan 5)Patient with serious heart disease 6)Patient with psychiatric disorder 7)Patient with uncontrollable diabetes 8)Patient with paresis of intestine, intestinal obstruction 9) Patient with the diarrhea 10)Patients with active severe infections 11) Patients with active concomitant malignancy 12)Patient with Active concomitant malignancy 13)Women during pregnancy or lactating 14) Refusal of contraception 15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Phase I Maximum tolerated dose Recommended dose Phase II Response Rate	—

Secondary

Measure	Time frame
Phase I Safety, Response rate, Phathologic response Phase II Safety, 3 year survival rate, Phathlogic response	—

Countries

Japan

Outcome results

None listed

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