UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053566 |
|---|---|
| Receipt number | R000058441 |
| Scientific Title | Clinical research on laparoscopic surgery for ovarian, fallopian tubal, and peritoneal cancer |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/07 16:34:35 |
* 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
Clinical research on laparoscopic surgery for ovarian, fallopian tubal, and peritoneal cancer
Acronym
Clinical research on laparoscopic surgery for ovarian, fallopian tubal, and peritoneal cancer
Scientific Title
Clinical research on laparoscopic surgery for ovarian, fallopian tubal, and peritoneal cancer
Scientific Title:Acronym
LAP-OVC
Region
| Japan |
Condition
Condition
ovarian cancer, tubal cancer, peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With recent advances in laparoscopic surgery equipment and techniques, laparoscopic surgery for gynecological malignancies has been actively performed overseas. In Japan, laparoscopic surgery for early-stage uterine cancer was approved in 2014, and laparoscopic surgery for early-stage cervical cancer in 2018, and the range of indications for laparoscopic surgery in the field of gynecology is expanding. In ovarian cancer (including fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors), laparoscopic surgery is less likely to be indicated because of the large tumor size and peritoneal seeding in many cases, but good results have been accumulated mainly overseas for early-stage ovarian cancer. In this study, we performed laparoscopic surgery to cure ovarian cancer (including fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors) in patients who were found to have malignant or borderline malignant tumors after oophorectomy and who required additional surgery, or whose lesions had disappeared or markedly shrunk after preoperative chemotherapy. The results were compared with those of laparoscopic surgery performed at the same time. This will allow us to select cases of ovarian cancer (including fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors), perform laparoscopic surgery, and evaluate its feasibility, safety, and prognosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of intestinal obstruction within 30 days of surgery
Key secondary outcomes
Perioperative complications (other than bowel obstruction) within 30 days of surgery, recurrence-free survival, and overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Open surgery for ovarian cancer (standard treatment)
Interventions/Control_2
Laparoscopic surgery for ovarian cancer
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Early ovarian cancer that can be removed without tumor failure (including tubal cancer and borderline malignant ovarian tumors)
2)Advanced stage ovarian cancer (Also includes borderline malignant ovarian tumors, including fallopian tube and peritoneal cancers) treated preoperatively and considered resectable
3)Patients with an ECOG Performance Status of 0 ~ 2
4)Patients with adequate major organ function (laboratory tests should be done within 28 days before surgery)
Neutrophil count 1,000/mm3 or greater, platelet count 100,000/mm3 or greater, AST, ALT 100 IU/L or less, serum total bilirubin < 1.5 mg/dl, serum creatinine < 1.5 mg/dl, normal ECG range or no symptoms and no need for treatment (Cases without heart disease or serious arrhythmias)
5)Patients aged 18 years or older at enrollment (upper limit not specified)
6)Patients who provided written consent to participate in the study
Key exclusion criteria
1)Patients who do not meet the inclusion criteria
2)Patients with serious complications
Example: Exclude patients with serious cardiac or cerebrovascular disease, difficult-to-control diabetes or hypertension with HbA1c > 8.5%, pulmonary fibrosis, interstitial pneumonia, bleeding, active peptic ulcer disease, or serious neurological disease.
3)Patients who are expected to have difficulty completing or following up with the study or who are deemed unsuitable by their physician
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kobayashi |
Organization
Oita University
Division name
Obstetrics and Gynecology
Zip code
879-5593
Address
1-1 Idaigaoka Hasama-Machi Yufu-City Oita Japan
TEL
097-586-5922
ekobayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Nishida |
Organization
Oita University
Division name
Obstetrics and Gynecology
Zip code
879-5593
Address
1-1 Idaigaoka Hasama-Machi Yufu-City Oita Japan
TEL
097-586-5922
Homepage URL
nishida@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Eiji Kobayashi
Funding Source
Organization
Delegated accounting funds for obstetrics and gynecology
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
Institutional Review Board
Address
1-1 Idaigaoka Hasama-Machi Yufu-City Oita Japan
Tel
097-549-4411
gcrcjimu@oita-u.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
| 2024 | Year | 02 | Month | 08 | 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
| 2023 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
