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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000024136 |
Receipt No. | R000027792 |
Scientific Title | Prospective cohort study of neoadjuvant chemotherapy using tri-weekly carboplatin and weekly paclitaxel for patients with locally advanced cervical cancer |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/09/23 |
Basic information | ||
Public title | Prospective cohort study of neoadjuvant chemotherapy using tri-weekly carboplatin and weekly paclitaxel for patients with locally advanced cervical cancer | |
Acronym | CC-NAC | |
Scientific Title | Prospective cohort study of neoadjuvant chemotherapy using tri-weekly carboplatin and weekly paclitaxel for patients with locally advanced cervical cancer | |
Scientific Title:Acronym | CC-NAC | |
Region |
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Condition | ||
Condition | cervical cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the efficacy and safety of neoadjuvant chemotherapy using tri-weekly carboplatin and weekly paclitaxel in patients with locally advanced cervical cancer. |
Basic objectives2 | Others |
Basic objectives -Others | To construct pathological mapping of residual tumor after neoadjuvant chemotherapy. |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 2 year recurrence free survival rate |
Key secondary outcomes | Response rate, Pathological CR rate, 2 year overall survival rate, Toxicity, Site of recurrence, Completion rate of the neoadjuvant chemotherapy |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Neoadjuvant chemotherapy (3 cycles of dose dense TC therapy)
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1. Histologically proven cervical cancer.
2. FIGO stage Ib2, IIa2, IIb. 3. ECOG Performance Status: 0 to 2. |
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Key exclusion criteria | 1. Previous chemotherapy.
2. Concomitant malignancy. 3. Severe complication. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hyogo Cancer Center | ||||||
Division name | Gynecologic Oncology | ||||||
Zip code | |||||||
Address | 13-70Kitaoji-cho, Akashi-city | ||||||
TEL | 078-929-1151 | ||||||
nagao@hp.pref.hyogo.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hyogo Cancer Center | ||||||
Division name | Gynecologic Oncology | ||||||
Zip code | |||||||
Address | 13-70Kitaoji-cho, Akashi-city | ||||||
TEL | 078-929-1151 | ||||||
Homepage URL | |||||||
nagao@hp.pref.hyogo.jp |
Sponsor | |
Institute | Hyogo Cancer CEnter |
Institute | |
Department |
Funding Source | |
Organization | Hyogo Cancer Center |
Organization | |
Division | |
Category of Funding Organization | Local Government |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | 兵庫県立がんセンター |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027792 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |