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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 | UMIN000027589 |
Receipt No. | R000030083 |
Scientific Title | Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer. |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2019/02/19 |
Basic information | ||
Public title | Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer. | |
Acronym | Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer. | |
Scientific Title | Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer. | |
Scientific Title:Acronym | Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer. | |
Region |
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Condition | |||
Condition | Esophageal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate safety and efficacy of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Recurrence free survival(RFS) |
Key secondary outcomes | Overall survival(OS)
Response rate(RR) R0 resction rate pN positive rate Adverse events |
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 DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
2.Clinical stage II or III (excluding T4) according to the 7th UICC-TNM classification 3.Age over 20 years old. 4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5.With or without evaluable lesions according to RECIST ver 1.1. 6.No prior treatment for esophageal cancer, except for (i)-(ii): (i)The depths of invasion are diagnosed as tumor invades lamina propria mucosa(pT1a-LPM) after a curative endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for esophageal cancer. (ii)The depths of invasion are diagnosed as tumor invades muscularis mucosa(pT1a-MM) and vascular invasion negative after a previous curative EMR or ESD for esophageal cancer. 7.No prior treatment of chemotherapy, radiotherapy or endocrine therapy against any other malignant tumors, except for hormone therapy for prostate cancer, which has improved before 5 years. 8.Adequate organ functions 9.R0 esophagectomy is expected 10.Written informed consent |
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Key exclusion criteria | 1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy
2.With active systemic infection disease 3.With active hepatitis B or C 4.With HIV infection 5.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6.Severe psychological illness. 7.With continuous systemic steroid or immune-suppressive drug therapy. 8.Poorly controlled diabetes mellitus or thyroid diseases. 9.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10.With a history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11.Pregnant and/or nursing women or men who wish to have children in future 12.Judged to be unfit to participate in this study by investigator |
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Target sample size | 55 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokyo | ||||||
Division name | Department of Gastrointestinal Surgery | ||||||
Zip code | |||||||
Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
seto-tky@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | The University of Tokyo | ||||||
Division name | Department of Gastrointestinal Surgery | ||||||
Zip code | |||||||
Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
Homepage URL | |||||||
yasuyoshi_s@hotmail.com |
Sponsor | |
Institute | The University of Tokyo |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
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 | |
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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 |
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 | |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
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=R000030083 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |