Unique ID issued by UMIN | UMIN000005055 |
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Receipt number | R000006007 |
Scientific Title | Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer. |
Date of disclosure of the study information | 2011/02/09 |
Last modified on | 2017/10/16 10:50:26 |
Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.
Adjuvant CDDP + VNR for pII-III NSCLC
Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.
Adjuvant CDDP + VNR for pII-III NSCLC
Japan |
Non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate the efficacy of adjuvant chemotherapy with cisplatin and vinorelbine for patients with completely resected pathological stage II-III non-small cell lung cancer
Efficacy
Confirmatory
Pragmatic
Phase II
Recurrence-free survival
Overall survival, adverse effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
adjuvant chemotherapy, consisting of cisplatin and vinorelbine
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Disease: patients with completely resected non-small cell lung cancer
Opetation mode: lobectomy, bilobectomy, or pneumonectomy with regional and mediastinal lymphnode disection.
Pathological stage: IIA, IIB, IIIA in UICC criteria
ECOG Performance status: 0 - 1.
No other active malignancies
Laboratory data:
WBC >= 4000 /mm3, Neutrophil >= 2000 /mm3, Hemoglobin >= 10 g/dl, Platelet >= 100,000 /mm3
GOT and GPT =< 2.5UNL
T-bil =< 1.5 mg/dl
s-Cre =< 1.5 mg/dl
PaO2 >= 65 mmHg or SpO2 >= 93%
Written informed consent
Patients receiving induction chemotherapy, radiotherapy for corresponding NSCLC
Patients receiving other postoperative chemotherapy / radiotherapy (Pleurodesis with OK-432 is excluded.)
Patients with other active malignancy.
Patients with active infection.
Patients with cardiac diseases which are not well-controlled.
Patients with interstitial lung diseases.
Patients with uncontrolled diabetes mellitus
Patients with a disease which needs steroid treatment
Patients who have allergy to CDDP or VNR
Patients in pregnancy or during lactation
60
1st name | |
Middle name | |
Last name | Hiroshi Date |
Kyoto University Hospital
Department of Thoracic Surgery
Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto
075-751-4975
1st name | |
Middle name | |
Last name | Makoto Sonobe |
Kyoto University Hospital
Department of Thoracic Surgery
Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto
075-751-4975
mysonobe@kuhp.kyoto-u.ac.jp
Department of Thoracic Surgery, Kyoto University Hospital
Donation for reseach in Department of Thoracic Surgery, Kyoto University Hospital
Self funding
JAPAN
NO
京都大学医学部附属病院(京都府)
2011 | Year | 02 | Month | 09 | Day |
Partially published
https://link.springer.com/article/10.1007%2Fs00280-014-2595-5
Purpose
Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients.
Methods
This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m2 of body surface area (BSA)] and cisplatin (40 mg/m2 of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety.
Results
Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0% (95% confidence interval 42.4-67.6%). Three- and five-year overall survival rates were 83.3 and 77.8%, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable.
Conclusions
Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.
Main results already published
2006 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 06 | Month | 01 | Day |
We are prepairing the report on the long-term results of enrolled patients.
2011 | Year | 02 | Month | 08 | Day |
2017 | Year | 10 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006007
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