UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056086 |
|---|---|
| Receipt number | R000064054 |
| Scientific Title | A pragmatic randomized controlled trial to confirm systemic anticancer therapy for patients with advanced solid tumors in the end-stage |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/11/19 11:59:58 |
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Basic information
Public title
A pragmatic randomized controlled trial to confirm systemic anticancer therapy for patients with advanced solid tumors in the end-stage
Acronym
TRUE trial
Scientific Title
A pragmatic randomized controlled trial to confirm systemic anticancer therapy for patients with advanced solid tumors in the end-stage
Scientific Title:Acronym
TRUE trial
Region
| Japan |
Condition
Condition
Advanced solid tumors for which treatments recommended by practice guidelines have been completed or are no longer available (breast cancer, lung cancer, stomach cancer, colon cancer, hepatobiliary pancreatic cancer, gynecologic cancer, urologic cancer)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Breast surgery | Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the standard of care, best supportive care (BSC), with chemotherapy (physician's choice) in terms of the effectiveness on overall survival (OS) and quality of life (QOL) for patients in the late stages of cancer chemotherapy for whom aggressive chemotherapies are not recommended.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
1) EORTC QLQ-C30 score
2) EQ-5D-5L score
3) Health Economics
4) Quality-adjusted life years (QALYs)
5) Length of hospital stay up to 12 weeks after enrollment
6) Number of scheduled outpatient visits up to 12 weeks after enrollment
7) Number of emergency room and unscheduled outpatient visits up to 12 weeks after enrollment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Physician's choice of drug therapy will be given to the study treatment group.
Interventions/Control_2
Best supportive care (BSC), the standard of care, will be given to the study control group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically diagnosed with solid cancer (breast cancer, lung cancer, stomach cancer, colorectal cancer, hepatobiliary pancreatic cancer, gynecological cancer [ovarian cancer, fallopian tube cancer, peritoneal cancer, cervical cancer, uterine cancer (including sarcoma)], urological cancer [prostate cancer, renal cancer, urothelial cancer]).
2) Advanced, metastatic, or recurrent cancer that is not resectable or radically irradiated.
3) Judged by attending physician that drug therapy is not aggressively recommended since all therapies recommended in the practice guidelines have been completed or judged to be unavailable.
4) There are drug therapies that are not recommended by practice guidelines but can be used.
5) Not scheduled to undergo gene panel testing.
6) 18 years and over at enrollment.
7) Performance status (PS) is 0, 1, or 2 according to ECOG criteria.
8) No measurable lesions are required.
9) No symptomatic brain metastases and no spinal metastases requiring radiation or surgical procedures.
10) Able to make outpatient visits.
11) Preserved organ function to receive drug therapies.
12) Able to complete QOL surveys using an electronic device.
13) Patient's written consent to participate in the study has been obtained.
Key exclusion criteria
1) Infectious disease requiring physical treatment.
2) Psychiatric disorders/symptoms that interfere with daily life and make it difficult to participate in the study.
3) Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
4) Judged difficult to participate in the study by the attending physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakasato |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Oncology Research
Zip code
169-0051
Address
1-1-7 Nishi-waseda, Shinjuku, Tokyo
TEL
03-5287-2636
Homepage URL
csp-qol@csp.or.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Iwatani, Tsuguo
Funding Source
Organization
National Institute of Public Health
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center
Address
1-1 Kanokodono, Chikusa, Nagoya, Aichi
Tel
052-762-6111
irb-jimu@aichi-cc.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
| 2024 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064054
