Unique ID issued by UMIN | UMIN000006389 |
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Receipt number | R000007572 |
Scientific Title | A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer |
Date of disclosure of the study information | 2011/09/21 |
Last modified on | 2021/10/08 16:33:09 |
A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
A Feasibility Study of Trimodality Therapy for Clinical Stage IIIA-N2 NSCLC
A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
A Feasibility Study of Trimodality Therapy for Clinical Stage IIIA-N2 NSCLC
Japan |
Non-small Cell Lung Cancer
Pneumology | Hematology and clinical oncology | Chest surgery |
Radiology |
Malignancy
NO
To evaluate feasibility of a trimodality therapy consisting preoperative induction chemoradiotherapy (weekly carboplatin [CBDCA] plus paclitaxel [PTX] with concurrent thoracic radiotherapy [50Gy]) as well as feasibility of postoperative consolidation chemotherapy (bolus CBDCA plus PTX) following the trimodality therapy, for resectable clinical stage IIIA-N2 (radiologically suspected and pathological confirmed mediastinal nodal metastasis) non-small cell lung cancer
Safety
Phase II
Complete Resection Rate after Surgary following Preoperative Induction Chemo-radiation Therapy
Disease-free Survival Rate at 2 Years
Progression-free Survival Rate at 2 Years
Overall Survival Rate at 2 Years
Effect of Preoperative Chemoradiation Therapy (Objective Radiological Response Rate,and Pathological Evaluation)
Completion Rate of Entire Protocol Treatment Consisting Preoperative Induction Chemoradiotherapy and Surgery followed by Postoperative Adjuvant Chemotherapy
Mortality and Morbidity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
Induction chemo-radiotherapy (weekly carboplatin [CBDCA] plus paclitaxel [PTX] with concurrent radiation [50Gy]) followed by surgery and postoperative consolidation chemotherapy (2 cycles of bolus CBDCA plus PTX)
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Histologicall or cytologically confirmed non-small cell lung cancer
2) Radiologicall suspected and pathologicall confirmed mediastinal nodal metastasis (N2)
Radiological suspicion of N2 isdefined as follows:
* Enlarged mediastinal node (1cm or more in the short-axis diameter) on CT, or
* Diagnosis of mediastinal nodal metastasis by a radiologist on FDG-PET scan
3) Expected complete tumor resection achieved with (bi-)lobectomy (or pneumonectomy) plus nodal dissection
Ineligible, if a mediastinal involved node showed extra-nodal invasion
4) V20 equal or less than 35% and Expected completion of planned radiation therapy judged by a radiation oncologist, based on 3-dimensional radiation therapy planning
5) No prior therapy for the current lung cancer
6) Patients is >=20 years and <75 years of age at the time of signature of the informed consent
7) ECOG performance status of 0 or 1
8) Expected residual forced expiratory volume in 1 second (FEV1.0) after surgery >=40% of estimated normal (FEV1.0), which was calculated based on each patient's height and weight
9) Adequate major organ function (including bone-marrow, heart, liver, renal function) as assessed by standard laboratory criteria as follows:
White blood cell >=4,000/mm3
Neutrophil >=2,000/mm3
Hemoglobin >=10.0g/dl
Platelet >=100,000/mm3
Serum albumin >=3.0g/dl
Total bilirubin <=1.5 mg/dL
AST, ALT <=100IU/L
Creatinin <=1.2mg/dL
Creatinin clearance >=60mL/min (calculated by the Cockcroft-Gault method, or measured by the 24-hour clearance method)
Arterial oxgen pressure measured by room air respiration (PaO2) >=70mmHg (not substitute for percutaneous oxygen [SpO2])
10) Written informed consent from the patient after adequate explanation of the study prior to the registration
1) CT revealed apparent extra-nodal invasion
2) The patient has active previous or concomitant malignancies (synchronous malignancies or metachronous malignancies with the disease-free interval of 5years or less), other than cured carcinoma in situ or intramucosal cancer
3) The patiet has uncontrolld hyoertension
4) The patient has uncontrolled diabetes mellitus
5) The patient has symptomatic congestive heart failure, uncontrolled arrhythmia or ischemic heart disease.
6) The patient has uncontrolled gastrointestinal bleeding or peptic ulcer.
7) The patients has active local or systemic infection, which should be treated
8) Positive serum HBs antigen (by quantitative or qualitative evaluation)
9) The patient has continual diarrhea, defined as watery stool (three times or more in one day)
10) The patients has intestinal paralysis or obstruction
11) The patient has a history of severe drug allergy
12) The patients has peripheral sensory or motor neuropathy of grade 2 or more at the time of registration
13) The patient has a history of allergy against agents containing polyoxyethilene oil containing (eg. Cyclosporine injection agent) or platinum agents
14) The patients has agents against alcoholism (eg. Disulfiram, cyanamide)
15) Chest roentogenogram shows apparent interstitial pneumonia or pulmonary fibrosis
16) The patient has persistent systemic (oral or intravenous) or intra-articular administration of steroids
17) The patient has psychiatric disorders that may comprise the patient's ability to comply with the study
18) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception.
19) The patient has a history of previous radiation therapy, and the radiation field is overlapped with the current radiation therapy field
20) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
40
1st name | |
Middle name | |
Last name | Fumihiro Tanaka |
University of Occupational and Environmental Health Hospital
Second Department of Surgery
1-1 Iseigaoka, Yahata-nishi-ku, Kitakyusyu, Fukuoka, 807-8555, Japan
093-691-7442
ftanaka@med.uoeh-u.ac.jp
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
datacenter
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2011 | Year | 09 | Month | 21 | Day |
Unpublished
Completed
2011 | Year | 09 | Month | 10 | Day |
2011 | Year | 10 | Month | 26 | Day |
2011 | Year | 10 | Month | 01 | Day |
2016 | Year | 11 | Month | 18 | Day |
2011 | Year | 09 | Month | 21 | Day |
2021 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007572
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