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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010116
Receipt No. R000011458
Scientific Title Clinical features of surgically resected patients with small-cell lung carcinoma -Intergroup analysis of Fukushima Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group-
Date of disclosure of the study information 2013/02/25
Last modified on 2020/03/02

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Basic information
Public title Clinical features of surgically resected patients with small-cell lung carcinoma -Intergroup analysis of Fukushima Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group-
Acronym Clinical features of surgically resected patients with small-cell lung cancer
Scientific Title Clinical features of surgically resected patients with small-cell lung carcinoma -Intergroup analysis of Fukushima Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group-
Scientific Title:Acronym Clinical features of surgically resected patients with small-cell lung cancer
Region
Japan

Condition
Condition small-cell lung carcinoma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the multidisciplinary approach including surgery to the patients with small-cell lung carcinoma and to clarify the clinical factors related to prognosis of those patients
Basic objectives2 Others
Basic objectives -Others retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To assess the multidisciplinary approach including surgery to the patients with small-cell lung carcinoma and to clarify the clinical factors related to prognosis of those patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients with histologically confirmed small-cell lung carcinoma resected surgically in the institutes affiliated with Fukushima Lung Cancer Study Group and/or Hokkaido Lung Cancer Clinical Study Group, and cooperation hospitals from Jan. 2003 through Jan. 2013.
Key exclusion criteria 1) Histologically undiagnosed disease
2) Patients without surgery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Ishida
Organization Fukushima Medical University Hospital
Division name Clinical Oncology Center
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1088
Email poroishida@gmail.com

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Yokouchi
Organization Fukushima Medical University, School of Medicine
Division name Department of Pulmonary Medicine
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1360
Homepage URL
Email hyokouch@gmail.com

Sponsor
Institute Fukushima Medical University Clinical Oncology Center
Institute
Department

Funding Source
Organization Fukushima Medical University Clinical Oncology Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1 Hikariga-oka, Fukushima
Tel 024-547-1825
Email rs@fmu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 25 Day

Related information
URL releasing protocol https://www.fmu.ac.jp/
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26604032
Number of participants that the trial has enrolled 156
Results
The results indicate that a history or presence of other types of cancer might be a major deci-sive factor for surgery. Patients with c-stages I and II (c-T2N1) can be considered for surgery, and PCI maybe useful in patients undergoing surgery in a practical setting, partly supporting the ESMO guidelines.
Results date posted
2020 Year 03 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 70 years, 34 patients were female, and 12 were never smokers. The median maximum tumor diameter was 20 mm.Ninety-six patients  received either a positron emissiontomography scan or PET-chest tomography  for exam-ination at the clinical stage. Most of the cases were c-stage IA. Three patients at p-stage IV had received systemic examination before surgery. One patient diagnosed with M1a had slight ipsilateral pleural effusion, of which the amountwas not enough for thoracentesis. Another patient diagnosed withM1a had ipsilateral pleural nodules, which had not been detectedby CT scan before surgery. One patient diagnosed with M1b hadsuffered from lumbago before surgery; however, bone scintigraphy demonstrated no signs for corresponding lesions. He did notreceive PET scan. His symptom got worse after surgery, and a lum-bar MRI revealed bone metastasis. Fifty-one patients (32.7%) had ahistory or presence of other types of cancer. Preoperative diagnosisof cancer was achieved in 82 (52.6%) patients. Combined SCLC wasdefined as the multiphasic malignant lung tumors containing anyproportion of SCLC cells according to the 2004 World Health Organization classification. The diagnoses of pure and combined SCLC were determined by the central pathological review board,and the number of patients in the two groups was 113 and 43 , respectively. The majority of the patients underwentlobectomy along with systematic mediastinal lymph nodedissection. Adjuvant chemotherapy, including chemora-diotherapy was conducted in 100  patients, of whom 13 received postoperative radiotherapy and four also underwent neo-adjuvant chemotherapy. Ninety-three patients receivedplatinum doublet. Thirteen patients received perioperative prophylacticcranial irradiation (PCI). Most of the 13 patients received either 25 Gray /10fractions or 30 Gy/15 fr. The median age of the patients undergo-ing PCI was 70 years, and the median follow-up timefrom PCI was 35.7 months . All 13 patients underwent adjuvant chemotherapy before PCI. Two of these patientsreceived neoadjuvant chemoradiotherapy followed by PCI beforesurgery. The median time to PCI from the date of surgery for theremaining 11 patients who received postoperative PCI was 5.7months. Recurrence was identified in four patients,one of whom had brain metastasis, 7.7 months after PCI with adose of 10 Gy/5 fr. According to the medical records, no treatment-related deteriorations, such as communication deficit, weakness oflegs, intellectual deficit, and memory loss were observed in any ofthe patients during the follow-up time.
Participant flow
Our eligibility criteria included patients with primary SCLCwho had undergone complete surgical resection of the primarylung tumor from January 2003 through January 2013 at institu-tions participating in either the Fukushima Investigative Group forHealing Thoracic Malignancy (FIGHT) or the Hokkaido Lung Can-cer Clinical Study Group Trial (HOT). Written informed consentwas obtained only from patients who were still alive at the timeof data accrual (from February 2013 through January 2014). Thestudy was registered with the University Hospital Medical Informa-tion Network (UMIN) Clinical Trials Registry, identification numberUMIN000010116, and approved by the Institutional Review Boardof each participating institution. All individual data were obtainedfrom medical records and de-identified. Stages were determinedor reclassified according to the seventh version of the tumor-node-metastasis (TNM) staging system. In the case of patients whounderwent either neo-adjuvant chemotherapy or neo-adjuvantchemoradiotherapy, c-stage was defined as the stage before thosetherapies.
Adverse events
not available
Outcome measures
Clinical variables that determine overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 02 Month 24 Day
Date of IRB
2013 Year 02 Month 25 Day
Anticipated trial start date
2013 Year 02 Month 25 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information 1 age
2 sex
3 date of diagnosis
4 past history/comorbidity
5 ECOG performance status
6 smoking history
7 date of surgery
8 surgical procedure
9 serum level of tumor markers such as proGRP and NSE, and LDH before surgery
10 longest diameter of the tumor
11 intrapulmonary location of the tumor
12 pre-operative result of cytology of the tumor
13 pathological result post surgery
14 diagnostic procedure
15 clinical and pathological stage
16 additional treatment such as chemotherapy and ratiotherapy
17 timing of chemotherapy (adjuvant/neo-adjuvant)
18 chemotherapy regimen
19 peri-operative treatment and adverse effect
20 prophylactic cranial irradiation
21 tumor response obtained by chemotherapy, radiotherapy, and chemoradiotherapy
22 recurrence site
23 clinical outcome, date of death, last follow up date

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2020 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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