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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 | UMIN000017720 |
Receipt No. | R000020527 |
Scientific Title | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2015/05/28 |
Basic information | ||
Public title | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer | |
Acronym | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer | |
Scientific Title | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer | |
Scientific Title:Acronym | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer | |
Region |
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Condition | |||
Condition | locally advanced rectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | safety and efficiency of induction chemotherapy(TS-1/L-OHP+/- Cetuximab) followed by chemoradiotherapy and surgery in locally advanced rectal cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | pathologival complete response rate |
Key secondary outcomes | Adverse event
Compliance to induction chemotherapy R0 resection rate Down-staging rate(T,N stage) Tumor regression grade LFS; local recurrence free survival RFS; Recurrence free survival OS; Overall survival |
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 | S-1/Oxaliplatin; treatment dose was decided by body mass index
Cetuximab was used only Kras wild type |
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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) T3 lower rectal cancer with mesorectal fascia involvement
2) T4a or T4b tumors 3) lateral lymph node swelling with the cut-off size larger 5mm measured on axial view at shorter axis. |
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Key exclusion criteria | inflammatory bowel disease
cardiac disease medical conditions that would not permit the patient to complete the study |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Meiwa Hospital | ||||||
Division name | Surgery | ||||||
Zip code | |||||||
Address | 4-31 Agenaruo-cho, Nishinomiya, Hyogo | ||||||
TEL | +81-798-47-1767 | ||||||
n_beppu@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Meiwa Hospital | ||||||
Division name | Surgery | ||||||
Zip code | |||||||
Address | 4-31 Agenaruo-cho, Nishinomiya, Hyogo | ||||||
TEL | +81-798-47-1767 | ||||||
Homepage URL | |||||||
n_beppu@yahoo.co.jp |
Sponsor | |
Institute | Meiwa Hospital department of surgery |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | |
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 | 明和病院(兵庫県) |
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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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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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=R000020527 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |