Unique ID issued by UMIN | UMIN000011083 |
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Receipt number | R000012973 |
Scientific Title | CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III |
Date of disclosure of the study information | 2013/08/01 |
Last modified on | 2018/07/12 17:51:30 |
CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III
Modified NAVAL study
CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III
Modified NAVAL study
Japan |
Non-squamous non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate the feasibility of neoadjuvant combination therapy of Cisplatin or Carboplatin, Pemetrexed, and Bevacizumab in patients with resectable clinical stage II/IIIA non-squamous non-small cell lung cancer
Safety
Exploratory
Not applicable
complete resection rate
Relapse free survival, 2Y,5Y survival, Response rate, Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
After Cisplatin or Carboplatin + Pemetrexed (500mg/m2) + Bevacizumab (15mg/kg) day 1 q3w 3 cycles, lung resection with lymph node dissection
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Histologically or pathologically proven non-squamous non-small cell lung cancer
2. Resectable clinical stage II/IIIA (UICC-7)
3. Without previously treatment for lung cancer
4. Age >=20, <75 y
5. ECOG PS 0-1
6. Expected FEV 1.0 > 1.0L after lung resection
7. Adequate organ function
8. Written informed consent
1. Uncontrollable systemic disease (hyper tension or diabetes mellitus)
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. Therapeutic anticoagulation; regular use of aspirin (>325 mg/day)
9. Severe GI disease
30
1st name | |
Middle name | |
Last name | Fumihiro Tanaka |
UOEH
Second Department of Surgery
1-1 Iseigaoka, Yahatanishi-ku,
093-691-7442
ftanaka@med.uoeh-u.ac.jp
1st name | |
Middle name | |
Last name | koushi kuroda |
UOEH
Second Department of Surgery
1-1 Iseigaoka, Yahatanishi-ku,
093-691-7442
kuroda-k@med.uoeh-u.ac.jp
UOEH
UOEH
Self funding
NO
2013 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2018 | Year | 08 | Month | 31 | Day |
2013 | Year | 07 | Month | 01 | Day |
2018 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012973
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