UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000037280 |
| Receipt No. | R000041395 |
| Scientific Title | Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2019/07/05 (Ver. 1) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| Basic information | ||
| Public title | Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer | |
| Acronym | LOGIK0406 | |
| Scientific Title | Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer | |
| Scientific Title:Acronym | LOGIK0406 | |
| Region |
|
|
| Condition | ||||
| Condition | advanced/recurrent non-small cell lung cancer (NSCLC) | |||
| Classification by specialty |
|
|||
| Classification by malignancy | Malignancy | |||
| Genomic information | NO | |||
| Objectives | |
| Narrative objectives1 | To evaluate the efficacy and tolerability of gemcitabine plus carboplatin for elderly patients with chemotherapy-naive non-small-cell lung cancer |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Phase II |
| Assessment | |
| Primary outcomes | Rresponse rate (RR)
|
| Key secondary outcomes | Progression free survival (PFS)
Overall survival (OS) Safety |
| 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 |
|
|
| Interventions/Control_1 | 1000mg/m2 of Gemcitabine plus AUC 3 of carboplatin were administered every two weeks and was continued until disease progression | |
| 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 |
|
|||
| Age-upper limit |
|
|||
| Gender | Male and Female | |||
| Key inclusion criteria | (1) Patients with histologically proven non-small cell lung cancer
(2) Patients with measurable disease (3) Chemotherapy in patients with unreliable Stage IIIb and Stage IV or in patients with postoperative relapse Untreated patients (4) Patients with a clinical signs Performance Status of 0 to 1 (5) Patients aged 70 years or older at enrollment (6) Patients who have not received prior chemotherapy, radiation therapy, or immunotherapy (BRM) (7) Major organ functions (bone marrow, liver, kidney, etc.) are well preserved, and the following criteria are used Patients who meet WBC count: 4,000 per mm3 and 12,000 per mm3 Neutrophils: 2,000 per mm3 or more Platelets count: 100,000 per mm3 or more Haemoglobin: 9.0 g/dl or more GOT and GPTs: less than 2.5 times the normal values of the institution Total bilirubin: not more than 2.0 mg/dl Serum creatinine: not more than 1.2 mg/dl PaO2 :>= 60 Torr (8) Patients who are expected to survive for more than 3 months (9) Patients with written informed consent to participate in the study |
|||
| Key exclusion criteria | (1) Patients with obvious infections
(2) Patients with fever (38C or higher) (3) Serious complications (heart disease, pulmonary fibrosis/interstitial pneumonia, bleeding tendency, uncontrolled) Patients with hypertension, diabetes mellitus, etc. (4) Patients with active double cancer (disease-free interval <5 years) (5) Symptomatic patients with brain metastases (6) Patients with pleural effusions and ascites requiring treatment (7) Patients with pericardial effusion (8) Patients with varicella (9) Patients with motor paralysis or peripheral nerve symptoms (excluding those originating from the primary disease) (10) Patients with a history of drug hypersensitivity (11) Pregnant, breastfeeding, and women of childbearing potential (willingness) (12) Other patients judged inappropriate by the investigator |
|||
| Target sample size | 48 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
|
||||||
| Organization | Kyoto Prefectural University of Medicine | ||||||
| Division name | Department of Pulmonary Medicine | ||||||
| Zip code | 6020841 | ||||||
| Address | 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan | ||||||
| TEL | 075-251-5513 | ||||||
| uchino@koto.kpu-m.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
|
||||||
| Organization | Kyoto Prefectural University of Medicine | ||||||
| Division name | Department of Pulmonary Medicine | ||||||
| Zip code | 602-0841 | ||||||
| Address | 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan | ||||||
| TEL | 075-251-5513 | ||||||
| Homepage URL | |||||||
| uchino@koto.kpu-m.ac.jp | |||||||
| Sponsor | |
| Institute | Clinical Research Support Center Kyushu |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Self funding |
| 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 | Kyoto prefectural University of Medicine |
| Address | 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan |
| Tel | 075-251-5513 |
| uchino@koto.kpu-m.ac.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 | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
|
||||||
| Related information | |
| URL releasing protocol | N/A |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | N/A | ||||||
| Number of participants that the trial has enrolled | 48 | ||||||
| Results | ORR: 29.2%(95%CI: 17.0-44.1) PFS: 178days(95%CI 122-198) OS: 398days |
||||||
| Results date posted |
|
||||||
| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | 48 patients were enrolled onto the study at 18 sites |
||||||
| Participant flow | The average number of cycles was 7, and 42% of patients received 8 cycles. |
||||||
| Adverse events | Neutropenia was the most common hematologic toxicity in total 68.8%. |
||||||
| Outcome measures | ORR: 29.2%(95%CI: 17.0-44.1) PFS: 178days(95%CI 122-198) OS: 398days |
||||||
| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| 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=R000041395 |
