UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012522 |
|---|---|
| Receipt number | R000014557 |
| Scientific Title | Efficacy and Safety of Cytokines Versus Sunitinib as First-line Followed by Second-line Axitinib in the Treatment of Patients with Metastatic Renal Cell Carcinoma: A Phase III Randomized Sequential Open-Label Study |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2023/01/16 13:12:45 |
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Basic information
Public title
Efficacy and Safety of Cytokines Versus Sunitinib as First-line Followed by Second-line Axitinib in the Treatment of Patients with Metastatic Renal Cell Carcinoma: A Phase III Randomized Sequential Open-Label Study
Acronym
ESCAPE Study
Scientific Title
Efficacy and Safety of Cytokines Versus Sunitinib as First-line Followed by Second-line Axitinib in the Treatment of Patients with Metastatic Renal Cell Carcinoma: A Phase III Randomized Sequential Open-Label Study
Scientific Title:Acronym
ESCAPE Study
Region
| Japan |
Condition
Condition
metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of cytokines versus sunitinib as 1st-line followed by 2nd-line axitinib in the treatment of patients with metastatic RCC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of cytokines followed by axitinib is superior compared to sunitinib followed by axitinib.
Key secondary outcomes
1. Overall survival (OS), descriptively in each arm
2. PFS in 1st-line and 2nd-line treatment, descriptively in each arm
3. Objective response rate (ORR) and disease control rate (DCR) in 1st-line and 2nd-line treatment, descriptively in each arm
4. Time to treatment failure (TTF) in 1st-line treatment, descriptively in each arm
5. Total TTF from 1st-line to 2nd-line treatment, descriptively in each arm
6. Safety 1st-line treatment, descriptively in each arm
7. Health-related Quality-of-life (HRQOL) in 1st-line and 2nd-line treatment, descriptively in each arm
3. PFS, ORR, and DCR in in 3rd-line and 4th-line treatment, descriptively in each arm
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cytokines (IL-2+ IFN) as 1st-line followed by 2nd-line Axitinib
Interventions/Control_2
Sunitinib as 1st-line followed by 2nd-line Axitinib
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who have already performed nephrectomy with metastatic renal cell carcinoma (RCC)
2. Patients with confirmed clear cell RCC
3. Patients who had not received any prior systemic treatment for metastatic RCC
4. Patients with the Memorial Sloan-Kettering Cancer Center (MSKCC) risk criteria of favorable or intermediate
5. Patients who have at least one measurable lesion on CT or MRI at baseline as per the RECIST 1.1 criteria
6. Age: 20-80 years old, both inclusive
7. Patients with ECOG performance status of 0 or 1
8. Patients with sufficient hematopoietic function who meet the following all criteria
- Neutrophil >= 1,500/mm3
- Platelet >= 10 times 104/mm3
- Hemoglobin > 9.0 g/dL
9. Patients with sufficient hepatic functions who meet the following all criteria
- Total-bilirubin <= 1.5 times ULN
- AST and ALT <= 2.5 times ULN (patients with hepatic metastasis <= 5.0 times ULN)
10. Patients with sufficient renal function who meet the following criterion
Serum creatinine <= 2.0 times ULN
11. Patients who are expected to have more than 3 months of life expectancy
12. Patients who gave informed consent for participation to the study after they received explanation of the briefing document
Key exclusion criteria
1. Patients with history of hypersensitivity against IFN, IL-2, Sunitinib, or Axitinib
2. Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby (including men)
3. Patients with a history of hypersensitivity to biological preparations such as vaccines
4. Patients having Shou-Sai-Kotou (special herbal drug)
5. Patients with autoimmune hepatitis
6. Patients with a history of interstitial pneumonia
7. Patients treated for another primary malignancy within 3 years of enrollment
8. Patients judged ineligible to participate in the study by the investigator
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Namiki |
Organization
Kanazawa University Hospital
Division name
Urology
Zip code
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2393
namiki@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Konaka |
Organization
Kanazawa University Hospital
Division name
Urology
Zip code
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2393
Homepage URL
h-konaka@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Innovative Clinical Research Center, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2013 | Year | 12 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014557
