![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000018484 |
Receipt No. | R000021400 |
Scientific Title | A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy |
Date of disclosure of the study information | 2015/08/01 |
Last modified on | 2015/08/05 |
Basic information | ||
Public title | A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy | |
Acronym | S-1 and Cetuximab Colon Cancer trial ( SACC trial ) | |
Scientific Title | A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy | |
Scientific Title:Acronym | S-1 and Cetuximab Colon Cancer trial ( SACC trial ) | |
Region |
|
Condition | |||
Condition | advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy | ||
Classification by specialty |
|
||
Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the Efficacy and safety of S-1 plus cetuximab in advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | PFS:Progression Free Survival |
Key secondary outcomes | Safety
ORR:Overall Response Rate OS:Overall Survival ETS:Early Tumor Shrinkage DpR:Deepness of Response RDI:Relative Dose Intensity TTP:Time to progression TTF:Time to treatment failure |
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 |
|
|
Interventions/Control_1 | S-1 was administered orally on days 1-14 of a 21-day cycle
cetuximab 400mg/m2 followed by weekly 250mg/m2 |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1) Histologically confirmed colorectal cancer.
2) unresectable primary lesion/distant metastasis/lymph node metastasis. In the case of recurrence, no treatment for the first recurrence leision after operation. 3) RAS wild-type. 4) Inappropriate for FOLFIRI, FOLFOX 5) Measurable leision by RECIST.(Ver.1.1) 6) No past history of chemotherapy 7) No past history of radiation therapy 8) Age; more than 65 years old. Life expectancy of more than 3 months. 9) ECOG Performance status 0-2. 10) Patiens have enough organ function for study treatment within 14 days before enrollment; 1 Hb>=9.0g/dL 2 WBC>=3,000/mm3, <12,000/mm3. 3 Neu>=1,500/mm3. 4 PLT>=10.0x104/mm3. 5 Total Bilirubin<=1.5mg/dL. 6 AST/ALT<=100 7 Creatinine<=1.2mg/dL. 8 Creatinine clearance estimation >=50mL/min 11) Oral intake is possible 12) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration 13) Written informed consent |
|||
Key exclusion criteria | 1) History of severe allergy
2) Active synchronous or metachronous malignancy 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 5) Massive pleural effusion or ascites 6) Wattery diarrhea 7) Prior treatment of cetuximab or L-OHP or TS-1 8) Patients who is receiving Flucytosine 9) Symptomatic brain metastasis 10) Pregnant or lactating women or women of childbearing potential 11) Severe mental disorders 12) Systemic administration of steroid 13) Severe renal failure, or urinary protein (more than 2+). 14) Prior radiotherapy for primary and metastases leision. 15) History of allergy for L-OHP and other platinating agent 16) Sensory alteration or paresthesia interfering with function. 17) Any other cases who are regarded as inadequate for study enrollment by the investigator. |
|||
Target sample size | 57 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | NHO HOKKAIDO CANCER CENTER | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | |||||||
Address | Kikusui4-2, Shiroishi-ku,Sapporo | ||||||
TEL | 011-811-9111 | ||||||
tsagawa@sap-cc.go.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | NHO HOKKAIDO CANCER CENTER | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | |||||||
Address | Kikusui4-2, Shiroishi-ku,Sapporo | ||||||
TEL | 011-811-9111 | ||||||
Homepage URL | |||||||
tsagawa@sap-cc.go.jp |
Sponsor | |
Institute | NHO HOKKAIDO CANCER CENTER
Division of Gastroenterology |
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 | 札幌医科大学医学部附属病院
徳島大学病院 国立病院機構 北海道がんセンター 斗南病院 東札幌病院 清田病院 王子総合病院 小樽エキサイ会病院 千歳市立病院 留萌市立総合病院 伊達赤十字病院 函館赤十字病院 製鉄記念室蘭病院 札幌共立五輪橋病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
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/ctr_e/ctr_view.cgi?recptno=R000021400 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |