UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052064 |
|---|---|
| Receipt number | R000059400 |
| Scientific Title | Lobectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L) |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/01/16 11:30:04 |
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Basic information
Public title
Lobectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L)
Acronym
Lobectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L)
Scientific Title
Lobectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L)
Scientific Title:Acronym
Lobectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L)
Region
| Japan |
Condition
Condition
clinical stage IA3 peripheral pure-solid non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized trial is to confirm the non-inferiority of segmentectomy to lobectomy in terms of overall survival for patients with clinical stage IA3 peripheral pure-solid non-small cell lung cancer (tumor size of greater than 2 cm and less than or equal to 3 cm, the absence of ground-glass opacity)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
relapse-free survival, postoperative respiratory function at 6 months and 1 year (FVC and FEV1.0), proportion of respiratory failure, proportion of cerebrovascular disease, cumulative incidence of death from other than primary lung cancer, cumulative incidence of local recurrence, proportion of patients who complete segmentectomy, number of resected segments, operative time, blood loss, adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary lobectomy
Interventions/Control_2
Pulmonary segmentectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria at primary registration
1) Fulfills all the following conditions on imaging studies
(i) cT1cN0M0 (stage IA3) NSCLC is suspected
(ii) Center of the tumor is located in the outer third of the lung field.
(iii) Pure-solid tumor (C/T ratio = 1, the absence of ground-glass opacity)
(iv) The tumor is not located at middle lobe.
2) No satellite tumors
3) Aged 18 years or older
4) Written informed consent
5) Fulfills both of the following conditions
(i) Predicted postoperative FEV1.0 >= 800 mL
(ii) Preoperative resting SpO2 >= 93%. If the resting SpO2 is <93%, PaO2 is >= 65 mmHg.
6) PS of 0 to 1
7) Sufficient organ function.
(i) White blood cell count >= 3,000/mm3
(ii) Hemoglobin >= 8.0 g/dL
(iii) Platelet count >= 100,000/mm3
(iv) AST <= 100 U/L
(v) ALT <= 100 U/L
(vi) Total bilirubin <= 2.0 mg/dL
(vii) Creatinine <= 1.5 mg/dL
8) No prior ipsilateral pulmonary resection (prior diagnostic thoracoscopy is allowed).
9) No prior chemotherapy or radiation therapy for any malignant diseases within 2 years. (Hormone therapy is allowed)
Inclusion criteria at Secondary registration (intraoperative)
1) Within 28 days of the primary registration
2) Histologically confirmed either adenocarcinoma, adenosquamous carcinoma, large cell carcinoma, sarcomatoid carcinoma, other epithelial tumors, salivary gland-type tumors, non-small cell lung cancer - NOS, large cell neuroendocrine carcinoma or carcinoid tumor.
3) Technically possible to perform lobectomy and segmentectomy.
4) No signs of malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lung regions.
Key exclusion criteria
1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.
2) Local or systemic active infection requiring treatment.
3) Pregnant, lactating, possibly currently pregnant.
4) Psychosis.
5) Systemic administration of steroids or immunosuppressive agents.
6) Patient who has severe drug allergy.
7) Comorbidities
(i) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema.
(ii) Uncontrollable diabetes (HbA1c > 8%).
(iii) Uncontrollable hypertension.
(iv) Unstable angina or history of myocardial infarction within 6 months prior to enrollment.
(v) Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
Target sample size
520
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsutani |
Organization
Kindai University
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
589-8511
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
yatsutani@msn.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Ethics Committee, Faculty of Medicine, Kinki University
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2035 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059400
