UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016176 |
|---|---|
| Receipt number | R000018777 |
| Scientific Title | Feasibility study on dose-dense paclitaxel and carboplatin therapy in combination with bevacizumab as neoadjuvant chemotherapy followed by interval debulking surgery in advanced ovarian cancer |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2021/10/30 15:51:47 |
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Basic information
Public title
Feasibility study on dose-dense paclitaxel and carboplatin therapy in combination with bevacizumab as neoadjuvant chemotherapy followed by interval debulking surgery in advanced ovarian cancer
Acronym
Feasibility study on ddTC plus Bev therapy (NAC) in ovarian cancer
Scientific Title
Feasibility study on dose-dense paclitaxel and carboplatin therapy in combination with bevacizumab as neoadjuvant chemotherapy followed by interval debulking surgery in advanced ovarian cancer
Scientific Title:Acronym
Feasibility study on ddTC plus Bev therapy (NAC) in ovarian cancer
Region
| Japan |
Condition
Condition
FIGO stage III-IV epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility including efficacy and safety of dose-dense paclitaxel and carboplatin therapy in combination with bevacizumab as neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) in advanced ovarian cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical completion rate
Key secondary outcomes
treatment completion rate, tolerability, adverse event, response rate, pathological remission rate, surgical invasiveness, progression free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
1. Neoadjuvant chemptherapy (NAC): 3 cycles of dose-dense paclitaxel and carboplatin therapy plus bevacizumab
2. Interval debulking surgery (IDS)
3. Postoperative chemotherapy: 3 cycles of dose-dense paclitaxel and carboplatin therapy plus bevacizumab and 16 cycles of bevacizumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patient diagnosed with FIGO stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by exploratory laparotomy or by clinical findings including cytology/biopsy, imaging studies, and tumor marker (CA125 >200U/mL and CEA <20ng/mL are eligible for the study)
2. ECOG Performance Status: 0-2
3. Adequate organ function (within 28 days prior to registration): absolute neutrophil count >=1.5 G/L, platelet count >=100 G/L, AST/ALT <=100 IU/L, total bilirubin <= 1.5 mg/dl, serum creatinine <= 1.5 mg/dl, proteinuria <= 1+, no abnormal finding to need treatment on 12-lead ECG, neuropathy (sensory and motor) grade <= 1
4. Patient expected to survive longer than 3 months
5. Age: 20 or older at registration
6. Patient must have signed informed consent
Key exclusion criteria
1. Patients who have received previous chemotherapy or radiation therapy to treat the current disease
2. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
3. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
4. Patient with active infection at registration
5. Patient suspected or diagnosed as arterial or venous thromboembolism at registration
6. Patients with gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, tumor invading deeply to intestinal tract, intra-abdominal inflammation, or intestinal obstruction
7.Patient with a history of hemoptysis (hemoptysis of fresh blood of 2.5ml or more)
8. Patient with a history of abdominal radiation therapy
9. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil, or alchohol
10. Pregnancy or during breast feeding or a patient willing to be pregnant
11.Patient who is judged inappropriate to participate in this study by the attending physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoki |
Organization
Keio University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211ext.62391
aoki@z7.keio.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nomura |
Organization
Keio University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211ext.62386
Homepage URL
hnomura@1998.jukuin.keio.ac.jp
Sponsor or person
Institute
Department of obstetrics and gynecology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3611
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34648082/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34648082/
Number of participants that the trial has enrolled
24
Results
The median age was 55.5 years (37-80 years), and high-grade serous carcinoma accounted for 18 patients. IDS was performed in all patients and the rate of complete surgery was 75%. The response rate in NAC was 79%, and CA125 declined below the cut-off in 58% of patients.
Neoadjuvant ddTC+Bev therapy was well tolerated, and the sufficient rate of complete surgery in IDS was obtained.
Results date posted
| 2021 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 14 | Day |
Baseline Characteristics
Ovarian, fallopian tube or primary peritoneal cancer patients with estimated stage III-IV
Participant flow
Twenty-four patients were included.
They received paclitaxel (80 mg/m2) on day1, 8, 15, carboplatin (AUC 6.0 mg/mL x minute) on day 1, and Bev (15mg/kg) on day 1 every 3 weeks as neoadjuvant chemotherapy. Interval debulking surgery (IDS) was performed after 3 cycles of ddTC+Bev therapy.
Adverse events
Grade 4 hematological toxicities: 29%
Grade 3/4 non-hematological toxicities: 17%
Grade 3/4 perioperative complications: 29%
Outcome measures
Primary endpoint: rate of complete surgery
Secondary endpoints: response rate and adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018777
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