PIT-2

JRCT ID: jRCTs031180403

Registered date:20/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary lung cancer
• Date of first enrollment: 18/04/2014
• Target sample size: 45
• Study type: Interventional
• Intervention(s): The surgical resection is performed after 3 cycles of induction concurrent chemoradiotherapy with CDDP, TS-1 and RT45Gy (1.8Gy/fra/day, 25fractions).

Outcome(s)

• Primary Outcome: 2-year progression-free survival

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) Histologically or cytologically proven squamous cel carcinoma of the lung, diagnosed using specimen material
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) 20 years or more , 75 years or less
(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

Exclude criteria

(1) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(2) Under administration of flucytosine
(3) History of active infection
(4) Hepatitis Bs antigen positive
(5) History of severe heart disease
(6) Traumatic fracture of un recovery
(7) Severe diarrhea
(8) Severe drug allergy
(9) Investigational new drug or the unapproved drug is administered
(10) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
(11) History of active double cancer
(12) History of pregnancy or lactation
(13) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Related Information

• Primary Sponsor: Suzuki Kenji
• Secondary ID(s): UMIN000012413