PIT-1

JRCT ID: jRCTs031180402

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary lung cancer
• Date of first enrollment: 03/02/2014
• Target sample size: 85
• Study type: Interventional

Intervention(s)

Group A: Induction chemotherapy (CDDP + PEM + BEV)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab.
Group B: Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy.

Outcome(s)

• Primary Outcome: 2-year progression-free survival

Secondary Outcome

(1)5-year progression-free survival
(2)2-year and 5-year overall survival
(3)Completion rate of the protocol treatment
(4)Complete resection rate
(5)Radiological response rate
(6)Down staging rate
(7)Safety
(8)Pathological response (Ef)
(9)Tumor markers (CEA/CYFRA)
(10)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 non-squamous non-small cell lung cancer, 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) 20years 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) 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 B surface 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

Related Information

• Primary Sponsor: Suzuki Kenji
• Secondary ID(s): UMIN000011941