UMIN-CTR Clinical Trial

Public title

Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)

Acronym

Adjuvant trial of CBDCA+TS1 followed by TS1 in completely resected stage II/IIA lung cancer. (JNETS1302)

Scientific Title

Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)

Scientific Title:Acronym

Adjuvant trial of CBDCA+TS1 followed by TS1 in completely resected stage II/IIA lung cancer. (JNETS1302)

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the feasibility of adjuvant CBDCA+TS1 followed by maintenance TS1 in patients with completely resected stage II-IIIA non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

The ratio of the patients who completed the treatment

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Carboplatin+TS1 followed by TS1 maintenance

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

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. ECOG performance status are 0 or 1.
2. Pathologically confirmed non-small cell lung cancer (NSCLC), except for low grade carcinoma such as carcinoid, mucoepidermoid carcinoma or adenoid cystic carcinoma.
3. Completely resected NSCLC by lobectomy or more
4. Lymph nodes dissection must be performed at the level of ND2a-1
5. Pathologically confirmed R0 resection.
6. Pathological stage II or IIIA
7. Within 2 months after surgical treatment
8. With adequate major organ functions within 14 days before trial entry, as defined below:
1) White blood cell count >= 3,000/mm3
2) Neutrophil count >= 1,500/mm3
3) Hemoglobin >= 8.0 g/dL
4) Platelet count >= 100,000/mm3
5) AST <= 100IU/L
6) ALT <= 100IU/L
7) Total Bilirubin<= 1.5 mg/dL
8) Serum Creatinine <= 1.5 mg/dL
9) SpO2 >= 95% at room air
10. Written informed consent must be taken by patients

Key exclusion criteria

1. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
2. With history of radiotherapy and/or chemotherapy for other disease including other cancer
3. With synchronous or metachronous (within 5 year before entry) multiple lung cancer
4. With synchronous or metachronous (within 5 year before entry) double cancer, except for curable cancer by local therapy such as in situ carcinoma
5. Severe surgical complication
6. Severe drug allergy
7. Severe complication; such as uncontrollable diabetes mellitus or hypertension
8. Positive for HBs antigen, HBs antibody, HBC antibody, HCV antibody or HIV antibody
9.Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
10. Men who have willing to become partner's pregnant
11.Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Suzuki

Organization

Fukushima Medical University

Division name

Department of Chest surgery

Zip code

Address

1 Hikarigaoka Fukushima, Fukushima JAPAN

TEL

024-547-1253

Email

hiro@fmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Chiaki Endoh

Organization

Tohoku University, school of medicine

Division name

Department of Thoracic surgery

Zip code

Address

4-1, Seiryo-machi, Aoba-ku, Sendai Miyagi JAPAN

TEL

022-717-8526

Homepage URL

Email

endo@idac.tohoku.ac.jp

Institute

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

Institute

Department

Personal name

Organization

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

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

Date of disclosure of the study information

2013

Year

07

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Open public recruiting

Date of protocol fixation

2013

Year

07

Month

24

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

29

Day

Last modified on

2013

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013243