![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004976 |
Receipt No. | R000005915 |
Scientific Title | A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02) |
Date of disclosure of the study information | 2011/03/01 |
Last modified on | 2018/06/14 |
Basic information | ||
Public title | A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02) | |
Acronym | A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02) | |
Scientific Title | A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02) | |
Scientific Title:Acronym | A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02) | |
Region |
|
Condition | ||||
Condition | Unresectable advanced/metastatic colorectal cancer | |||
Classification by specialty |
|
|||
Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the effectiveness and safety of S-1/oxaliplatin (SOX)+bevacizumab combination therapy in patients with unresectable advanced/metastatic colorectal cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Progression free survival, Overall survival, Incidence and degree of 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 |
|
||
Interventions/Control_1 | Patients receive infusional oxaliplatin, bevacizumab, and oral TS-1 every 21 days. | ||
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 (adenocarcinoma).
2) Clinically proven unresectable advanced/ metastatic colorectal cancer 3) 20 to 79 years of age 4) ECOG performance status 0-1 5) Presence of measurable lesion 6) No previous history of chemotherapy or radiotherapy for unresectable advanced/ metastatic colorectal cancer 7) Oral food intake possible 8) Adequate organ functions 9) Estimated life expectancy more than 3 months 10) Written informed consent |
|||
Key exclusion criteria | 1) History of serious drug hypersensitivity
2) Pregnant or possibly pregnant females, or males with female partners who are planning to pregnancy 3) Severe infectious disease 4) Severe comorbidity (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, uncontrollable hypertension, uncontrollable diabetes mellitus, etc) 5) Comorbidity or history of heart failure 6) Evidence of gastrointestinal ulcer or bleeding 7) Peripheral neuropathy 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Clinical or radiological evidence of CNS metastases. 11) Current or previous (within the last 6 months) history of GI perforation 12) Previous history of thrombosis or cerebral infarction 13) Any surgical treatments within 28 days 14) Evidence of bleeding diathesis or coagulopathy 15) ongoing treatment with anticoagulant or aspirin (> 325mg/day) 16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 17) Previous history of adjuvant chemotherapy with oxaliplatin 18) Under coutinuous steroid administration 19) Any other serious or uncontrolled condition which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 20) Previous history of hemoptysis 21) Contraindication for administration of L-OHP, BV, TS-1, 5-FU, or l-LV 22) Presence of severe colorectal stricture 23) Radiological evidence of peritoneal dissemination |
|||
Target sample size | 55 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Hiroshima Prefectural Hospital | ||||||
Division name | Clinical Oncology | ||||||
Zip code | |||||||
Address | 1-5-54 Ujina-Kanda, Minami-ku, Hiroshima, 734-8530, JAPAN | ||||||
TEL | 082-254-1818 | ||||||
k-shinozaki@hph.pref.hiroshima.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Hiroshima University Hospital | ||||||
Division name | Gasroenterological Surgery | ||||||
Zip code | |||||||
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN | ||||||
TEL | 082-257-5222 | ||||||
Homepage URL | |||||||
tsukoba@hiroshima-u.ac.jp |
Sponsor | |
Institute | Hiroshima Study group of Clinical Oncology (HiSCO) |
Institute | |
Department |
Funding Source | |
Organization | Hiroshima Study group of Clinical Oncology (HiSCO) |
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 | 安佐市民病院(広島県)、井野口病院(広島県)、太田川病院(広島県)、尾道総合病院(広島県)、呉医療センター(広島県)、呉市医師会病院(広島県)、県立広島病院(広島県)、庄原赤十字病院(広島県)、中国労災病院(広島県)、中電病院(広島県)、土谷総合病院(広島県)、東広島医療センター(広島県)、広島市民病院(広島県)、広島大学病院(広島県)、広島鉄道病院(広島県)、広島西医療センター(広島県)、三次中央病院(広島県)、柳井医療センター(山口県)、吉田総合病院(広島県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | http://hisco-jpn.com/pdf/HiSCO-02outline.pdf |
Publication of results | Published |
Result | |
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/27803845 |
Number of participants that the trial has enrolled | |
Results | PURPOSE:FOLFOX is a standard combination chemotherapy regimen for metastatic colorectal cancer (CRC). 5-Fluorouracil (5-FU) is infused continuously through a pump for 46 h; therefore, replacement of infused 5-FU with oral S-1 would be more convenient for patients. We investigated the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab regimen in a community setting. METHODS:We conducted a phase II clinical study in Hiroshima, Japan. We enrolled individuals aged 20-80 years who had metastatic CRC, an Eastern Cooperative Oncology Group performance status of 0 or 1, assessable lesions, and not received previous chemotherapy. Eligible patients were administered SOX plus bevacizumab (S-1 80 mg/m2/day, day 1-14 orally; and oxaliplatin 130 mg/m2 day 1 i.v., bevacizumab 7.5 mg/kg, day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. RESULTS:Between May 2011 and January 2014, 55 patients (mean age 64 years) were enrolled at 12 institutions. Median follow up duration was 20.2 months (range 1.3-47.1 months). RR was 47.1 % [95 % confidence interval (CI) 33.7-60.6 %]. Median PFS and OS was 9.2 months (95 % CI 7.6-10.8) and 22.5 months (95 % CI 19.4-25.9), respectively. Major adverse events (grade 3/4) were neutropenia (9.3 %), thrombocytopenia (5.6 %), anorexia (18.5 %), and sensory neuropathy (16.7 %). CONCLUSION:These data suggested that SOX plus bevacizumab is effective and capable of being managed in metastatic CRC patients in our community clinical practice. |
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 | 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/ctr_e/ctr_view.cgi?recptno=R000005915 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |