臨床研究等提出・公開システム

A multicentre, single arm, confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy (66Gy) followed by surgical resection in patients with superior sulcus tumor.

CRES3T

61

Median age was 62 years. There were 53 male and 8 female, 1 never smoker and 60 smokers. Clinical stages were stage IIB in 32 and stage IIIA in 23 patients. Tumor invasion sites were chest wall in 57, subclavian artery/vein in 18/10 patients. Tumor histologic types were adenocarcinoma in 30, squamous cell carcinoma in 20, and others in 11 patients.

Between June 2014 and March 2019, 61 patients were enrolled in CRES3T and received induction therapy as part of the safety analyses. One patient with distant metastasis that manifested after starting induction therapy (retroactively ineligible case) was excluded from the efficacy analyses. Forty-nine patients underwent surgery.

Although no new treatment-related adverse events occurred during the induction therapy, two patients developed and succumbed to pneumonia. One patient died due to sudden cardiac arrest on postoperative day 3.

The 3-year overall survival (primary endpoint) was 73.2% (95% confidence interval: 60.1-82.7%) . The 3-year progression-free survival rates was 53.3% (95% confidence interval: 40.0-65.0%) . The objective and pathological complete response rates were 42% (95%confidence interval: 29-54%) and 33% (95% confidence interval: 20-46%) , respectively. The patterns of first tumor relapse were locoregional only in one, distant metastasis only in 18, and both in four patients.

The study treatment strategy was defined to be considered useful, if the lower limit of the 95% confidence interval of the 3-year overall survival rate was greater than the threshold of 60% in the protocol. The 3-year overall survival rate was 73.2% (95% confidence interval: 60.1-82.7%) . Therefore, protocol treatment of this study was considered useful because the lower bound of the 95% CI of 3-year OS exceeded the 60% threshold.

July. 01, 2025

Mar. 19, 2025

https://doi.org/10.1016/j.lungcan.2025.108506.

No

No.

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180401

Suzuki Kenji

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

kjsuzuki@juntendo.ac.jp

Takamochi Kazuya

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

+81-3-3813-3111

ktakamo@juntendo.ac.jp

Complete

July. 01, 2014

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

(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

(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

Both

Primary lung cancer

The surgical resection is performed after 3 cycles of induction concurrent chemoradiotherapy with CDDP, TS-1 and RT66Gy(2Gy/fra/day, 33fractions).

Superior sulcus tumor

Induction chemoradiotherapy, Surgery

3-year overall survival

- 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

+81-4-7133-1111

Mar. 14, 2019

none