UMIN-CTR Clinical Trial

Public title

The differences in prognostic factors between pathological stage I invasive squamous cell carcinoma and adenocarcinoma of the lung.

Acronym

The differences in prognostic factors between pathological stage I invasive squamous cell carcinoma and adenocarcinoma of the lung.

Scientific Title

The differences in prognostic factors between pathological stage I invasive squamous cell carcinoma and adenocarcinoma of the lung.

Scientific Title:Acronym

The differences in prognostic factors between pathological stage I invasive squamous cell carcinoma and adenocarcinoma of the lung.

Region

Japan

Condition

pathological stage I invasive squamous cell carcinoma and adenocarcinoma of the lung.

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Surgery is considered as the most effective treatment for resectable non-small cell lung cancer (NSCLC). The postoperative survival rate remains unsatisfactory even after complete tumor resection. Although some randomized clinical trials have evaluated the role of adjuvant chemotherapy in patients with resected stage-I NSCLC, the benefits remain uncertain. Identification of factors associated with the development of local recurrence or distant metastasis after surgical resection may be useful to stratify patients with higher risks in the future design of clinical trials for aggressive adjuvant therapy.
Squamous cell carcinoma (Sq) and adenocarcinoma (Ad) are the two major histologic types of NSCLC. Many small Ads are relatively dormant bronchioloalveolar carcinomas and have favorable outcome among non-smoker patients. On the other hand, Sq mostly develops in smokers, in whom life-threatening co-morbidities often develop, which may leads the poorer survival rates of patients with Sq compared with those with Ad. Many studies of resected specimens have been performed to determine various clinicopathological prognostic factors other than the pathological stage for early stage patients. However differences in biological behaviors between Sq and Ad focused on the clinicopathological factors are not well understood. Based on our patient database, we retrospectively examined the survival differences between surgically resected stage I Sq and Ad, in an attempt to elucidate the difference of prognostic impacts and to incorporate it in future TNM staging systems.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

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

Patients with pathological stage I primary lung Ad or Sq were enrolled in this retrospective study. They all underwent surgically complete resection from January 1996 through December 2010 at our two institutes.

Key exclusion criteria

Patients who had received preoperative chemotherapy or thoracic radiotherapy were excluded. We also excluded patients with Ad which was pathologically proven as a pre-invasive lesion such as atypical adenomatous hyperplasia and lung adenocarcinoma in situ.

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, Tokyo, Japan

Division name

Division of General Thoracic Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

TEL

03-5363-3806

Email

kohno@1993.jukuin.keio.ac.jp

Name of contact person

1st name
Middle name
Last name	Mitsutomo Kohno

Organization

Department of Surgery, Keio University School of Medicine, Tokyo, Japan

Division name

Division of General Thoracic Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

TEL

03-5363-3806

Homepage URL

http://plaza.umin.ac.jp/~thorkeio/index.html

Email

kohno@1993.jukuin.keio.ac.jp

Institute

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

Institute

Department

Personal name

Organization

none

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、済生会宇都宮病院

Date of disclosure of the study information

2014

Year

03

Month

07

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

02

Month

24

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a retrospective study. There is no new candidate.

Registered date

2014

Year

03

Month

07

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=R000015595