A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer

A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer - Personalized Induction Therapy Clinical Trial-2(PIT-2)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012413

Enrollment

Registered

2013-11-27

Start date

2013-12-01

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

Stage IIIA-N2 Squamous, Non-small cell lung cancer

Interventions

Induction concurrent chemoradiotherapy (CDDP +TS-1+ RT45Gy) The surgical resection is performed after 3 cycles of chemotherapy with CDDP, TS-1 and RT45Gy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically proven squamous cel carcinoma of the lung, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node (2) Stage IIIA- pathologically proven N2 disease (3) Without previously treatment for lung cancer (4) Age >=20, <=75 y (5) ECOG PS 0-1 (6) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95% (7) Adequate organ function (8) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.) (2) Current history of hemosputum or hemoptysis (3) Evidence of bleeding diathesis or coagulopathy (4) Cavity in lung tumor or great vessel involvement (5) Current or previous (within the last 1 year) history of cerebrovascular disease (6) Traumatic fracture of un recovery (7) History of active infection (8) Hepatitis Bc antibody or hepatitis Bs antigen positive (9) Therapeutic anticoagulation; regular use of aspirin (>325 mg/day) (10) Severe GI disease (11) Current or previous (within the last 1 year) history of GI perforation or diverticultis (12) History of severe heart disease (13) Severe diarrhea (14) Severe drug allergy (15) Investigational new drug or the unapproved drug is administered (16) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp (17) History of active double cancer (18) History of pregnancy or lactation (19) 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
2-year progression-free survival	—

Secondary

Measure	Time frame
-5-year progression-free survival -2-year and 5-year overall survival -Completion rate of the protocol treatment -Complete resection rate -Radiological response rate -Down staging rate -Safety -Pathological response (Ef) -Tumor markers (CEA/CYFRA) -SUVmax on FDG-PET scan	—

Countries

Japan

Contacts

Public ContactKazuya Takamochi

Juntendo University Thoracic Surgery

ktakamo@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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