UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000000522 |
| Receipt No. | R000000628 |
| Scientific Title | A randomized phase III trial of AP(Doxorubicin+Cisplatin) versus DP(Docetaxel+Cisplatin), TC(Paclitaxel+Carboplatin) as adjuvant chemotherrapy in patients with high risk group of endometrial carcinoma |
| Date of disclosure of the study information | 2006/11/15 |
| Last modified on | 2019/03/22 (Ver. 31) |
* 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 | A randomized phase III trial of AP(Doxorubicin+Cisplatin) versus DP(Docetaxel+Cisplatin), TC(Paclitaxel+Carboplatin) as adjuvant chemotherrapy in patients with high risk group of endometrial carcinoma | |
| Acronym | A randomized phase III trial of AP versus DP, TC regimens for high risk group of endometrial carcinoma | |
| Scientific Title | A randomized phase III trial of AP(Doxorubicin+Cisplatin) versus DP(Docetaxel+Cisplatin), TC(Paclitaxel+Carboplatin) as adjuvant chemotherrapy in patients with high risk group of endometrial carcinoma | |
| Scientific Title:Acronym | A randomized phase III trial of AP versus DP, TC regimens for high risk group of endometrial carcinoma | |
| Region |
|
|
| Condition | ||
| Condition | patients with high risk group of endometrial carcinoma which is removed surgically | |
| Classification by specialty |
|
|
| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The purpose is to compare the progression-free survival (PFS) of AP regimen as adjuvant chemotherapy with that of DP regimen and that of TC regimen for high risk group of endometrial carcinoma |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | Phase III |
| Assessment | |
| Primary outcomes | Progression-free survival |
| Key secondary outcomes | overall survival, toxicity, tolerability, status of lymphadenectomy |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Active |
| Stratification | YES |
| Dynamic allocation | YES |
| Institution consideration | Institution is not considered as adjustment factor. |
| Blocking | NO |
| Concealment | Central registration |
| Intervention | ||
| No. of arms | 3 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
|
|
| Interventions/Control_1 | Doxorubicin 60 mg/m2 + CDDP 50 mg/m2 day 1 q 3 weeks
6 courses |
|
| Interventions/Control_2 | Docetaxel 70 mg/m2 + CDDP 60 mg/m2 day 1 q 3 weeks
6 courses |
|
| Interventions/Control_3 | Paclitaxel 180 mg/m2 + CBDCA AUC 6 day 1 q 3 weeks
6 courses |
|
| 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 | Female | |||
| Key inclusion criteria | 1)Histologically confirmed endometrial carcinoma
2)Hysterectomy, bilateral adnexectomy and pelvic lymphadenectomy are performed and a residual tumor size is less than 2cm 3)Endometrial carcinoma with the following either requirements by histologic diagnosis of primary lesion -stage I or II more than myometrial invasion 1/2, and grade 2 or 3 -stage III -stage IV without diatant metastasis to beyond the abdominal cavity 4)No prior chamotherapy and radiotherapy for endomatrial carcinoma 5)At least 2 weeks since prior hormonal therapy 6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 7)Within 8 weeks after the operation 8)More than 20 years old and less than 75 years old 9)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 10)Written informed consent |
|||
| Key exclusion criteria | 1)Patients with sarcomatous element
2)Active infections 3)Serious complications (heart disease, uncontrolled diabetes mellitus, malignant hypertension and tendency to bleeding) 4)Active concomitant malignancy 5)Interstitial pneumonitis and plumonary fibrosis 6)Massive pleural effusion or ascites 7)Neuropathy grade 2 or more (NCI-CTC) 8)Edema grade 2 or more (NCI-CTC) 9)prior chemotherapy including doxorubicin 10)Hypersensitivity to Polysorbate 80 or Cremophor EL 11)Patients judged inappropriate for this study by the physicians |
|||
| Target sample size | 780 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
|
||||||
| Organization | School of Medicine, Keio University | ||||||
| Division name | Department of Obstetrics and Gynecology | ||||||
| Zip code | |||||||
| Address | 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan | ||||||
| TEL | 03-3353-1211 | ||||||
| jgog2043@jgog.gr.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
|
||||||
| Organization | JGOG2043 Coordinating Office | ||||||
| Division name | Department of Obstetrics and Gynecology, School of Medicine, Keio University | ||||||
| Zip code | |||||||
| Address | 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan | ||||||
| TEL | 03-3353-1211 | ||||||
| Homepage URL | http://www.jgog.gr.jp/ | ||||||
| jgog2043@jgog.gr.jp | |||||||
| Sponsor | |
| Institute | Japanese Gynecologic Oncology Group |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Ministry of Health, Labour and Welfare |
| Organization | |
| Division | |
| Category of Funding Organization | |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | Japanese Gynecologic Oncology Group |
| 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 |
|
||||||
| Related information | |
| URL releasing protocol | https://www.jgog.gr.jp/ |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/30896757 | ||||||
| Number of participants that the trial has enrolled | 788 | ||||||
| Results | https://www.ncbi.nlm.nih.gov/pubmed/30896757 |
||||||
| Results date posted |
|
||||||
| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | https://www.ncbi.nlm.nih.gov/pubmed/30896757 |
||||||
| Participant flow | https://www.ncbi.nlm.nih.gov/pubmed/30896757 |
||||||
| Adverse events | https://www.ncbi.nlm.nih.gov/pubmed/30896757 |
||||||
| Outcome measures | https://www.ncbi.nlm.nih.gov/pubmed/30896757 |
||||||
| 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/icdr_e/ctr_view.cgi?recptno=R000000628 |
