UMIN-CTR Clinical Trial

Public title

The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung

Acronym

The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung

Scientific Title

The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung

Scientific Title:Acronym

The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung

Region

Japan

Condition

peripheral squamous cell carcinoma of the lung

Classification by specialty

Surgery in general

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Squamous cell carcinomas (SqCCs) of the lung account for 20-30% of non-small cell lung cancers (NSCLC). Although the majority of SqCCs of the lung have histologically been reported to arise in the central bronchial regions, the incidence of SqCCs arising in the peripheral lung has increased over recent years. Several reports have revealed a low prevalence of lymph node metastasis in peripheral SqCCs (p-SqCCs), especially in tumors 2 cm or less in diameter. These facts support the idea that SqCCs remain localized and grow slowly compared with lung adenocarcinoma. However the characteristics and biological behaviors of p-SqCCs including prognostic factors remain to be elucidated.
Pathologically proven lymphovascular and pleural invasion are generally correlated with poor outcome and they could predict cancer recurrence in NSCLC. Visceral pleural invasion is defined as invasion beyond the elastic layer and T1 tumors with pleural invasion is upgraded to T2a in the 7th TNM classification. Vascular invasion is also significantly correlated with cancer recurrence in early stage NSCLC. Although vascular and pleural invasion are useful prognostic factors for NSCLC, this has not yet been established especially among p-SqCCs patients. In this retrospective study, we evaluated several clinicopathological variables in patients with p-SqCCs in an attempt to identify reliable prognostic factors.

Basic objectives2

Others

Basic objectives -Others

New proposal of TNM classification in peripheral squamous cell carcinoma of the lung.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

overall survival, recurrence free survival

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

They all underwent complete resection of p-SqCCs from January 1995 through December 2011 at our two institutes. All the patients had a solitary lesion.

Key exclusion criteria

Patients who had received preoperative chemotherapy or thoracic radiotherapy were excluded.

Target sample size

Name of lead principal investigator

1st name
Middle name
Last name	Mitsutomo Kohno

Organization

Department of Surgery, Keio University School of Medicine

Division name

Division of General Thoracic Surgery

Zip code

Address

35 Shinanomachi, Shinjukuku, Tokyo, Japan

TEL

03-5363-3806

Email

kohno@a3.keio.jp

Name of contact person

1st name
Middle name
Last name	Mitsutomo Kohno

Organization

Department of Surgery, Keio University School of Medicine

Division name

Division of General Thoracic Surgery

Zip code

Address

35 Shinanomachi, Shinjukuku, Tokyo, Japan

TEL

03-5363-3806

Homepage URL

Email

kohno@a3.keio.jp

Institute

Division of General Thoracic Surgery, Department of Surgery, Keio University School of Medicine

Institute

Department

Personal name

Organization

Division of General Thoracic Surgery, Department of Surgery, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院

Date of disclosure of the study information

2014

Year

03

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

03

Month

13

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2015

Year

03

Month

31

Day

Other related information

The result of this trial will be presented in academic meeting and article.

Registered date

2014

Year

03

Month

13

Day

Last modified on

2015

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015645