UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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
Acronym
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
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Dose escalation part: The incidence of dose limiting toxicity
Expansion part: The ratio of patients who completed the prescribed treatment
Key secondary outcomes
Dose escalation part: Safety, Response rate, Progression free survival
Expansion part: Response rate, Progression free survival, 2 years survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy
Interventions/Control_2
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Omori |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
Homepage URL
s.omori@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka cancer center
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
Shizuoka cancer center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
(+81)055-989-5222
irb@scchr.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
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）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs042180077
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34495421/
Number of participants that the trial has enrolled
19
Results
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.
Results date posted
| 2022 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 08 | Day |
Baseline Characteristics
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.
Participant flow
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.
Adverse events
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.
Outcome measures
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.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017171
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/05 | 研究計画書 (高齢者Cb+NabPTX+RT) ver1.5(2015.06.19) 最終IRB承認(2015.07.06).pdf |
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