UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008205 |
|---|---|
| Receipt number | R000007836 |
| Scientific Title | Phase II study of induction therapy: S-1 and cisplatin with concurrent radiation for patient with stage IIA-IIIA locally advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2012/06/19 |
| Last modified on | 2021/02/15 20:38:36 |
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Basic information
Public title
Phase II study of induction therapy: S-1 and cisplatin with concurrent radiation for patient with stage IIA-IIIA locally advanced non-small cell lung cancer.
Acronym
Induction therapy of S-1 and cisplatin with concurrent radiation for NSCLC
Scientific Title
Phase II study of induction therapy: S-1 and cisplatin with concurrent radiation for patient with stage IIA-IIIA locally advanced non-small cell lung cancer.
Scientific Title:Acronym
Induction therapy of S-1 and cisplatin with concurrent radiation for NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of induction chemoradiotherapy of cisplatin and S-1 with concurrent radiation for the patients with advanced stage IIA-IIIB non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate for the schedule
Key secondary outcomes
Safety, 3-yr and 5-yr survival rate,3-yr and 5-yr relapse free survival rate.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cisplatin plus TS-1 combination induction chemoradiotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Provided written informed consent
2)NSCLC with histologic proof(without LCNEC)
3)Resectable pathological stage IIA to IIIB NSCLC (proved by E-BUS/TBMA or mediastinoscopy for lymph node metastasis)
4)More than age 20 years old
5)No previous treatment
6)No double cancer
7)Sufficient oral intake
8)Performance status (PS) 0 or 1
9)Normal ECG
10)Patients also had to have adequate organ function
Key exclusion criteria
1)Stage II without lymph node metastasis, stage IIIA with single N2, and stage IIIB with N3beta or gamma
2)Patients with a history of drug hypersensitivity
3)Patients with administration of phenitoin or potassiun warfarin
4)Patients with administration of flucytosine
5)Active infection
6)Active ulcer in digestive tract
7)Serious nonsurgical complications
8)Diarreha
9)Pregnant
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Nagayasu |
| Middle name | |
| Last name | Takeshi |
Organization
Nagasaki Graduate School of Biomedical Sciences
Division name
Division of Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7304
nagayasu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoshi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Nagasaki Graduate School of Biomedical Sciences
Division name
Division of Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7304
Homepage URL
tomoshi@nagasaki-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology, Nagasaki Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dpt. of Surgical Oncology, Nagasaki University Hospital
Address
1-7-1 Sakamoto Nagasaki
Tel
0958197304
tomoshi@nagasaki-u.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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s11748-018-01058-3
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s11748-018-01058-3
Number of participants that the trial has enrolled
23
Results
The actual number of patients enrolled was 23, and 20 were able to complete the surgery. Three patients dropped out because of patient refusal, leukopenia, or ALK-positive PD. 12 of the 20 patients had SD, and 8 had PR. All surgeries were complete resections, including lobectomies or more, two lobectomies in two patients, and combined resections of the chest wall in six patients. Postoperative pathology revealed a down stage in 13 patients, and the tumor component disappeared in 4 patients.
Results date posted
| 2021 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The actual number of registered cases was 23, with stage IIB 5, IIIA 18, and pathological diagnosis of adenocarcinoma 12, squamous cell carcinoma 6, and others 5.
Participant flow
Patients will receive 2 courses of preoperative induction chemotherapy using cisplatin 60mg/m2 (intravenous infusion on day 8) + TS-1 80-120mg/day (TS-1 granule fraction 2, 2 weeks continuous administration, 2 weeks rest) for 4 weeks per course, and concurrent radiotherapy (2Gy/day total 40Gy). Standard surgery (lobectomy or more + 2 groups lymph node dissection or more) is performed for patients with unchanged (NC) or improved (PR to CR) disease.
Adverse events
Adverse events included Grade 3 leukopenia, neutropenia, and Grade 2 thrombocytopenia as hematologic toxicity, and Grade 3 diarrhea, pneumonia, nausea, hepatic dysfunction, Grade 2 hypophagia, and esophagitis as non-hematologic toxicity.
Outcome measures
Primary endpoint: completion rate against schedule
Secondary endpoint: explore safety, 3- and 5-year survival, 3- and 5-year relapse-free survival, relapse rate, toxicity, response rate, and predictors of chemotherapy efficacy against schedule
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007836
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/02/15 | CDDP-TS-1 radiation110626.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
