UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006304 |
|---|---|
| Receipt number | R000007463 |
| Scientific Title | Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer. |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2016/03/07 19:27:53 |
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Basic information
Public title
Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer.
Acronym
Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer.
Scientific Title
Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer.
Scientific Title:Acronym
Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer.
Region
| Japan |
Condition
Condition
advanced and recurrent rectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I : To determine the maximum tolerated dose (MTD) and recommended dose (RD) of TS-1 / oxaliplatin / Cetuximab / Radiation in patients with KRAS wild type advanced and recurrent rectal cancer.
Phase II : To evaluate safety and efficacy of TS-1 / oxaliplatin / Cetuximab / Radiation in patients with KRAS wild type advanced and recurrent rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I:To determine maximum tolerated dose and recommended dose.
Phese II:pCR rate.
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Radiotherapy with two parallel opposed lateral fields will be administered in fractions of 1.8 Gy/day, given 5 days per week for 25 days. The total dose of radiation will be 45 Gy.
TS-1 (80-120mg/day) will be given orally two times per day on Days 1-5, 8-12, 22-26, and 29-33. Oxaliplatin is administered intravenously at day 1 and day 22. The initial dose of Oxaliplatin was 75 mg/m2 (Level 1), given to 3 patients. The dose will be increased in a stepwise fashion, and 3 other patients will receive the next dose level until the MTD will be reached. Cetuximab administered intravenously in dosage of level at day1, day8, day15, day22, day29.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histopathological confirmation of rectal cancer.
2. Locally advanced or recurrent cancer.
3. KRAS wild type (codon12,13).
4. Previous chemotherapy completed at least 4 weeks before inclusion.
5. >=Age 20
6. ECOG performance status of 0 to 1.
7. Expected more than 3 months survival.
8. Sufficient function of important organs
1.Leu:4,000/mm3 to 12,000/mm3
2.Neu : >= 2,000 /mm3
3.Platelet : >= 100,000 /mm3
4.hemoglobin : >= 9.0 g/dL
5.AST, ALT : < 100 IU/L
6.St.bil : < 2.0 mg/dL
7.Ccr : >= 60 ml/min
9. Ability to ingestion intake and drug administration orally.
10. Informed consent is obtained.
Key exclusion criteria
1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
2) No radiation therapy
3) Allergic to a drug
4) Patients under treatment with flucytosine.
5) Sensory neuropathy
6) Metastasis to CNS.
7) Intestinal paralysis or ileus
8) Massive pleural or abdominal effusion.
9) Active infection and inflammation.
10) Watery stools or diarrhea.
11) Severe complications
12) Pregnant or lactating
13) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Ikeda, Tsunekazu Mizushima |
Organization
Graduate School of Medicine, Osaka Univesity
Division name
Department of Surgery, Gastroenterolgical Surgery
Zip code
Address
E2-2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3251
tmizushima@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tunekazu Mizushima |
Organization
Graduate School of Medicine, Osaka
Division name
Department of Surgery, Gastroenterolgical Surgery
Zip code
Address
2-2-E2 Yamadaoka SUita Osaka
TEL
06-6879-3251
Homepage URL
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka Univesity
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka Univesity
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
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
| 2011 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007463
