![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000011941 |
Receipt No. | R000013941 |
Scientific Title | A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer |
Date of disclosure of the study information | 2013/10/02 |
Last modified on | 2018/09/04 |
Basic information | ||
Public title | A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer | |
Acronym | Personalized Induction Therapy Clinical Trial-1:PIT-1 | |
Scientific Title | A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer | |
Scientific Title:Acronym | Personalized Induction Therapy Clinical Trial-1:PIT-1 | |
Region |
|
Condition | ||
Condition | Stage IIIA-N2 Non-squamous, Non-small cell lung cancer | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safty of preoperative induction concurrent chemoradiotherapy(CDDP + PEM + RT45Gy) and preoperative induction chemotherapy (CDDP + PEM + BEV) for Stage IIIA-N2 non-squamous, non-small cell lung cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | 2-year progression-free survival |
Key secondary outcomes | 5-year progression-free survival
2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | "Group A : Induction chemotherapy (CDDP + PEM + BEV)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab. " |
|
Interventions/Control_2 | "Group B :Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy. " |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | "1. Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
2. Stage IIIA- pathologically proven N2 disease 3. Without previously treatment for lung cancer 4. Age 20-75 y 5. ECOG PS 0-1 6. Expected FEV 1.0 ,over800ml after lung resection, SpO2 Room air over95% 7. Adequate organ function 8. Written informed consent " |
|||
Key exclusion criteria | "1.Uncontrollable systemic disease.hyper tension, diabetes mellitus etc.
2. Current history of hemosputum or hemoptysis 3. Evidence of bleeding diathesis or coagulopathy 4. Cavity in lung tumor or great vessel involvement 5. Current or previous within the last 1 year history of cerebrovascular disease 6. Traumatic fracture of un recovery 7. History of active infection 8. hepatitis B surface antigen positive 9. Therapeutic anticoagulation; regular use of aspirin ,over 325 mg/day. 10. Severe GI disease 11. Current or previous within the last 1 year history of GI perforation or diverticultis 12. History of severe heart disease 13. Severe diarrhea 14. Severe drug allergy 15. Investigational new drug or the unapproved drug is administered 16. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 17. History of active double cancer 18. History of pregnancy or lactation 19. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator " |
|||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Hiroshima University | ||||||
Division name | Thoracic Surgery | ||||||
Zip code | |||||||
Address | 1-2-3 kasumi minami-ku Hiroshima,Hiroshima | ||||||
TEL | 082-257-5869 | ||||||
morihito@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Juntendo University | ||||||
Division name | Thoracic Surgery | ||||||
Zip code | |||||||
Address | 3-1-3Hongo Bunkyo-ku,Tokyo | ||||||
TEL | 03-3813-3111 | ||||||
Homepage URL | |||||||
ktakamo@juntendo.ac.jp |
Sponsor | |
Institute | Advanced Clinical Trial chest surgery Group (ACTG)
|
Institute | |
Department |
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 | |
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 | 大分大学医学部附属病院(大分県)
がん・感染症センター都立駒込病院(東京都) がん研有明病院(東京都) 岐阜大学医学部附属病院(岐阜県) 倉敷中央病院(岡山県) 神戸大学医学部附属病院(兵庫県) 国立がん研究センター東病院(千葉県) 産業医科大学病院(福岡県) 順天堂大学医学部附属順天堂医院(東京都) 聖マリアンナ医科大学病院(神奈川県) 仙台厚生病院(宮城県) 東京医科大学病院(東京都) 鳥取大学医学部附属病院(鳥取県) 広島市立広島市民病院(広島県) 広島大学病院(広島県) 福島県立医科大学附属病院(福島県) 山形県立中央病院(山形県) 山口大学医学部附属病院(山口県) 横浜市立大学付属市民総合医療センター(神奈川県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | No longer recruiting | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013941 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |