Unique ID issued by UMIN | UMIN000014764 |
---|---|
Receipt number | R000017171 |
Scientific Title | A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer |
Date of disclosure of the study information | 2014/08/12 |
Last modified on | 2022/08/11 09:52:27 |
A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
Japan |
Non-small-cell lung cancer
Pneumology | Radiology |
Malignancy
NO
To determine the recommended dose and evaluate feasibility of Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
Safety
Phase I
Dose escalation part: The incidence of dose limiting toxicity
Expansion part: The ratio of patients who completed the prescribed treatment
Dose escalation part: Safety, Response rate, Progression free survival
Expansion part: Response rate, Progression free survival, 2 years survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy
75 | years-old | <= |
Not applicable |
Male and Female
1)Cytologically or histologically confirmed non-small-cell lung cancer
2)Unresectable locally advanced non-small-cell lung cancer (stage III)
3)When radio-oncologist judged that the patients can tolerable for full dose irradiation
4)No prior chemotherapy and thoracic radiotherapy
5)At least one measurable lesion
6)Aged 75 or more
7)ECOG Performance status of 0-1
8)Sufficient major organ function
9)Life expectancy of at least 90 days
10)Written informed consent
1)Active double cancer
2)History of severe infections or complications
3)HBs antigen positive
4)History of thoracic radiotherapy
5)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis
6)Severe emphysema, chronic bronchitis, asthma
7)History of drug-induced pneumonia or severe drug allergies
8)Uncontrolled diabetes despite continuing treatment of insulin
9)Unstable angina, cardiac infarction within 6 months before enrollment
10)Obvious abnormality of the electrocardiogram
11)Grade 2 or higher peripheral neuropathy
12)A fever of over 38 degrees
13)Continuous systemic administration of steroid or immunosuppressant
14)Patients with severe mental illness
15)Unsuitable patients judged by the attending physician
40
1st name | Toshiaki |
Middle name | |
Last name | Takahashi |
Shizuoka cancer center
Division of Thoracic Oncology
4118777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
(+81)055-989-5222
t.takahashi@scchr.jp
1st name | Shota |
Middle name | |
Last name | Omori |
Shizuoka cancer center
Division of Thoracic Oncology
4118777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
(+81)055-989-5222
s.omori@scchr.jp
Shizuoka cancer center
Shizuoka cancer center
Self funding
Shizuoka cancer center
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
(+81)055-989-5222
irb@scchr.jp
NO
静岡県立静岡がんセンター(静岡県)
大阪市立総合医療センター(大阪府)
関西医科大学附属枚方病院(大阪府)
大分県立病院(大分県)
2014 | Year | 08 | Month | 12 | Day |
https://jrct.niph.go.jp/latest-detail/jRCTs042180077
Published
https://pubmed.ncbi.nlm.nih.gov/34495421/
19
Brief summary:
Weekly nab-paclitaxel plus carboplatin combined with concurrent thoracic radiotherapy is associated with a high treatment completion rate and exhibits promising safety and efficacy in elderly patients with locally advanced NSCLC. Based on these results, a randomized phase III study of chemoradiotherapy for elderly patients with locally advanced NSCLC comparing weekly nab-paclitaxel plus carboplatin with daily carboplatin (JCOG1914) is currently enrolling.
2022 | Year | 08 | Month | 11 | Day |
2021 | Year | 09 | Month | 08 | Day |
The median age was 81 years (range, 75-88 years). Seventeen (89%) patients were male, 12 (53%) of these patients had an ECOG-PS of 0, and nine (47%) had stage IIIA (UICC 7th edition). Twelve (63%) patients were diagnosed with adenocarcinoma, five (26%) with squamous cell carcinoma, and two (11%) with other non-small cell carcinoma.
Between July 2014 and December 2018, 19 patients at four institutions were enrolled. Of these, eight patients were enrolled in the dose escalation study, and 11 patients were enrolled in the expansion study. Among the 19 patients, protocol treatment was completed in 17 patients, and protocol treatment was discontinued in two patients.
In total, 17 patients, including the six patients who had received treatment at the recommended dose in the dose-escalation study, were evaluated for tolerability, safety, and efficacy.
Five serious adverse events were reported during the observation period of this study. Of these, one treatment-related death was observed.
(1) Grade 3 lung infection, outcome: recovering, relationship to study treatment: yes
(2) Grade 3 pneumonitis, outcome: recovering relationship to study treatment: yes
(3) Grade 5 pneumonitis, outcome: death, relationship to study treatment: yes
(4) Grade 2 esophagitis*1, outcome: recovering, relationship to study treatment: yes
(5) Grade 3 cholecystitis, outcome: recovering, relationship to study treatment: none
*1: Prolonged symptoms of esophagitis, requiring hospitalization.
The recommended nab-paclitaxel dose was set at 30 mg/m2 because two patients experienced dose-limiting toxicity at 40 mg/m2. The treatment completion rate of the 17 patients analyzed at the recommended dose was 100% (80% confidence interval (CI), 83.8-100%). The overall response rate was 76.5%, the median progression-free survival was 13.4 months (95%CI, 4.2-21.4 months), the median survival time was 36.1 months (95% CI, 11.8-not reached), and two-years survival rate was 64.7% (95% CI, 40.4-83.2%).
Among the 13 patients with confirmed disease progression, the initial site of disease progression was locoregional in seven patients, distant in five patients and locoregional with distant in one patient.
Completed
2014 | Year | 07 | Month | 29 | Day |
2014 | Year | 07 | Month | 29 | Day |
2014 | Year | 08 | Month | 12 | Day |
2020 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2014 | Year | 08 | Month | 05 | Day |
2022 | Year | 08 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017171