UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003237 |
|---|---|
| Receipt number | R000003848 |
| Scientific Title | A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC) |
| Date of disclosure of the study information | 2010/02/23 |
| Last modified on | 2015/03/27 17:14:22 |
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Basic information
Public title
A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)
Acronym
A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)
Scientific Title
A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)
Scientific Title:Acronym
A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)
Region
| Japan |
Condition
Condition
anal canal caner
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I part: to evaluate maximum tolerated dose and dose-limiting toxicities to determine recommended dose of S-1 in combination with a fixed dose of mitomycin C (MMC) plus radiation therapy in patients with stage II/III squamous cell carcinoma of the anal canal.
Phase II part: to evaluate the efficacy and safery of combination chemoraditotherapy with S-1 plus MMC in patients with stage II/III squamous cell carcinoma of the anal canal.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Phase I: Incidence of dose limiting toxicity
Phase II: Proportion of 3 year event-free survival
Key secondary outcomes
Phase I: Incidence of adverse events
Phase II: Complete response rate, progression-free survival, event-free survival, over all survival, colostomy-free survival, incidence of adverse events, and febril neutropenia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Combination chemoradiotherapy consists of S-1(day1-14, 29-42, 40-80mg/m2/day), MMC(day1,29, 10mg/m2), and radiotherapy(59.4Gy/33Fr)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Lesion located in anal canal
2) Histologically proven squamous cell carcinoma or basaloid carcinoma
3) Clinical stage II or III (TNM-UICC 6th, 2002)
4) Phase I part: aged 20 to 75 years old, phase II part: aged 20 to 80 years old
5) ECOG Performance status 0 or 1
6) Both measurable lesions and unmeasurable lesions
7) No previous therapy against anal canal cancer
8) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancer
9) Sufficient oral intake
10) Adequate organ functions
11) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Pregnant or lactating women or women of childbearing potential
4) Psychosis
5) Patients requiring systemic steroids medication
6) Serum HBs antigen positive
7) Anti-HIV antibody positive
8) Uncontrollable diabetes mellitus or administration of insulin.
9) Uncontrollable hypertention
10) Unstable angina, heart failure, or with a history of myocardial infarction within 6 months.
11) Interstitial pneumonia, fibroid lung, or severe emphysema
12) Active bacterial or fungous infection
13) fever over 38 degrees centigrade
Target sample size
71
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hamaguchi |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Medical Oncology
Zip code
Address
5-1-1Tsukiji, Chuo-ku, Tokyo, 105-0043, Japan.
TEL
03-3542-2511
thamaguc@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ito |
Organization
JCOG0903 Coordinating Office
Division name
National Cnacer Center Hosipital, division of radiation oncology
Zip code
Address
5-1-1Tsukiji, Chuo-ku, Tokyo, 105-0043, Japan.
TEL
03-3542-2511
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
札幌厚生病院（北海道）
岩手医科大学（岩手県）
宮城県立がんセンター（宮城県）
山形県立中央病院（山形県）
栃木県立がんセンター（栃木県）
群馬県立がんセンター（群馬県）
防衛医科大学校（埼玉県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
順天堂浦安病院（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
東京医科大学病院（東京都）
がん・感染症センター都立駒込病院（東京都）
慶應義塾大学病院（東京都）
東京医科歯科大学（東京都）
北里大学東病院（神奈川県）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
昭和大学横浜市北部病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
富山県立中央病院（富山県）
石川県立中央病院（石川県）
長野市民病院（長野県）
岐阜大学医学部（岐阜県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
藤田保健衛生大学（愛知県）
国立病院機構京都医療センター（京都府）
大阪大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪市立総合医療センター（大阪府）
大阪医科大学（大阪府）
市立堺病院（大阪府）
市立吹田市民病院（大阪府）
関西労災病院（兵庫県）
兵庫医科大学（兵庫県）
広島市立広島市民病院（広島県）
県立広島病院（広島県）
広島市立安佐市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
高知医療センター（高知県）
久留米大学医学部（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 23 | Day |
Last modified on
| 2015 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003848
