UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000010116
Receipt number	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 18:56:03

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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

small-cell lung carcinoma

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

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 or person

Institute

Fukushima Medical University Clinical Oncology Center

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011458