UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012237 |
|---|---|
| Receipt number | R000014309 |
| Scientific Title | Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2013/11/08 |
| Last modified on | 2022/01/18 15:03:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Acronym
Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title
Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title:Acronym
Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Completely resected non-squamous non-small cell lung cancer patients (pathologic stage II-IIIA)
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the prognostic and predictive biomarkers for NSCLC cancer treated with Cisplatin plus Pemetrexed or Vinorelbine
Basic objectives2
Others
Basic objectives -Others
Biomarker study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of somatic gene mutation and gene expression in tumor tissue
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%.
2) Pathologic stage II or IIIA (UICC TNM Classification 7th edition)
3) Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R; present/ absent) (regardless of the type of determination method)
4) Complete resection* is pathologically confirmed.
*Complete resection is the surgical procedure which removes lung cancer to the R0 level. However, when cancer metastasis is found in the uppermost part of a dissected or sampled lymph node in R0 (un) cases, the case is defined as "incomplete resection". R1 (is) and R1(cy+) are also defined as "incomplete resection".
5) The level of surgical resection is higher than lobectomy.
6) ND2a-1 or higher-level lymph node dissection or selective lymph node dissection has been conducted.
7) No other treatments except surgery have been carried out for lung cancer.
8) The age is within 20-75 years inclusive.
9) A performance status (ECOG) of 0 or 1.
10) Registration was made at 21 or more days after surgery but within 56 days after surgery.
11) The functions of the main organs are maintained, and all the criteria stated below are satisfied.
(Laboratory test values should be the most recent findings obtained within 14 days before registration, although the findings made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.)
* Hemoglobin: >=9.0 g/dl
* WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3)
* Platelet count: >=100,000/mm3
* Both AST and ALT: <=100 IU/L
* Total bilirubin: <=1.5 mg/dl
* Serum creatinine: <=1.5 mg/dl
* Creatinine clearance: >=60 ml/min (actual measurement or the value obtained using the Cockcroft-Gault formula)
12) PaO2: >=70 Torr or SpO2: >=95% in the state of no oxygen inhalation (room climate)
13) Submission of written informed consent concerning study participation.
Key exclusion criteria
1) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung.
2) Previously treated with cisplatin, pemetrexed or vinorelbine
3) Administration of folic acid or Vitamin B12 is not possible.
4) Serious post-operative complications (post-operative infections, suture failures, etc.)
5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT
6) Active infection
7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study.
8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women.
Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period.
9) History of serious drug hypersensitivity
10) Other serious complications
11) Others judged by the investigator to be unsuitable for the study
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Nishio |
Organization
Kinki University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, 589-8511, Japan
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Sakai |
Organization
Kinki University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, 589-8511, Japan
TEL
072-366-0221
Homepage URL
kasakai@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
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
TCOG, TORG, CJLSG, West Japan Oncology Group, JMTO, Setouchi Lung Cancer Study Group, LOGIK.
Name of secondary funder(s)
Kinki University Faculty of Medicine, Department of Genome Biology
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cas.14730
Number of participants that the trial has enrolled
389
Results
The study demonstrated the significance of tumor mutation burden as a biomarker for predicting the recurrence-free survival of pemetrexed/cisplatin in stage II-IIIA non-squamous non-small cell lung cancer patients.
Results date posted
| 2021 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not applicable
Participant flow
not applicable
Adverse events
not applicable
Outcome measures
not applicable
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2013 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014309
