CRES3T

JRCT ID: jRCTs031180401

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: 07/08/2014
• Target sample size: 60
• Study type: Interventional
• Intervention(s): The surgical resection is performed after 3 cycles of induction concurrent chemoradiotherapy with CDDP, TS-1 and RT66Gy(2Gy/fra/day, 33fractions).

Outcome(s)

• Primary Outcome: 3-year overall survival

Secondary Outcome

- 3-year and 5-year progression-free survival
- 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 non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
(2) Chest MRI or thoracic CT, direct invasion of the primary lesion to the organ of one of the following is suspected.
a) Invasion to the first rib or more superior chest wall
b) Subclavian vein or subclavian artery
(3) cN0, cN1
(4) Patients with evaluable lesions or measurable disease
(5) 20years or more, 75 years or less
(6) ECOG PS 0-1
(7) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95%
(8) Adequate organ function
(9) Written informed consent

Exclude criteria

(1) Distant metastasis
(2) malignant pleural effusion, pericardial effusion, intrathoracic seeding.
(3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(4) Case with the administration of the flucytosine.
(5) Severe drug allergy
(6) Infection requiring intravenous administration of anti-viral agents antibiotics, or antifungals
(7) Hepatitis Bs antigen positive
(8) History of severe heart disease , Current or previous (within the last 1 year) history of myocardial infarction
(9) Traumatic fracture of unrecovery ,a high degree of wound
(10) Severe diarrhea
(11) Investigational new drug or the unapproved drug is administered
(12) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
(13) History of active double cancer
(14) History of pregnancy or lactation or Women suspected of being pregnant.Men who wish to make a child. or no intention to contraception
(15) 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): UMIN000014386