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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002845
Receipt No. R000003450
Scientific Title Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
Date of disclosure of the study information 2009/12/04
Last modified on 2015/09/19

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Basic information
Public title Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
Acronym SOX-RT(P-I)
Scientific Title Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
Scientific Title:Acronym SOX-RT(P-I)
Region
Japan

Condition
Condition Rectal cancer of Stage II or III with T4 or lateral lymph node metastasis at the pre-operative diagnosis
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD), and identify a feasible oxaliplatin dose for combination therapy of S-1 and concurrent radiation against stage II or III distal rectal cancer with T4 or lateral lymph node metastasis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes the MTD and RD of oxaliplatin
Key secondary outcomes Adverse events, radiologic and pathologic tumor response, surgical morbidity

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 Maneuver
Interventions/Control_1 1)S-1 at a dose of 80mg/m2/day orally in 2 divided doses for 5 days a week during radiotherapy
2) Weekly oxaliplatin at a dose of 40-60mg/m2 intravenously
3) Radiotherapy is delivered a total irradiation dose of 50.4 Gy given in daily fractions of 1.8 Gy, 5 days a week and additional exposure for 3 times.
4) Surgery
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed Rectum cancer (adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, adenosquamous carcinoma)
2. Preoperative findings (Must meet all the conditions)
i.Main lesion of the tumor is located at the Rs, Ra, Rb, or P
ii. Lower tumor margin is below the peritoneal reflection
iii. With lateral LN metastasis (internal iliac lymph nodes, obturator lymph nodes or common iliac lymph nodes (Shorter diameter of LN is less than 10 mm or more by pelvic CT or MRI)), or T4

3. No evidence of distant metastasis
4. age:20-75years old
5. ECOG PS:0 or 1
6. With or without target lesion by RECIST
7. Without prior anti-cancer therapy
8. Adequate oral intake
9. Adequate organ function
10.Written IC
Key exclusion criteria 1. Suspected metastasis of external iliac lymph nodes, para-aortic lymph nodes, or inguinal lymph nodes by pelvic MRI.
2. Prior or synchronous invasive malignancy (expect carcinoma in situ or superficial carcinoma which is able to eradicate by local therapy) unless disease free for a minimum of 5 years
3. Evidence of active bacterial or fungal infection (existing fever above 38 degrees centigrade due to infection)
4. Previous history of severe drug-induced allergy
5. Need to treatment with flucytosine, atazanavir sulfate, or warfalin
6. Need systemic administration of corticosteroids
7. Evidence of positive hepatitis B virus surface antigen
8. Evidence of severe watery diarrhea
9. Evidence of uncontrolled diabetic mellitus
10. Evidence of uncontrolled hypertension
11. Need to intervention for heart disease according to the findings of electrocardiogram within the last 28 days
12. Myocardial infarction or unstable angina pectoris within the last 12 months
13. Major surgery within 4 weeks of study enrollment (other than diverting colostomy)
14. Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, advanced emphysema, heart disease which is difficult to manage, renal failure, hepatic failure)
15. Pregnant or lactating and woman with childbearing potential who lacked effective contraception
16. Evidence of psychiatric disability interfering with enrollment to clinical trial
17.Patients judged inappropriate for this study by the physicians
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Ohue
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Surgery
Zip code
Address 1-3-3 Nakamichi, higashinari-ku, Osaka City, Osaka Prefecture
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Ohue
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email ohue-ma@mc.pref.osaka.jp

Sponsor
Institute National cancer center hosital
Institute
Department

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
Email

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
2009 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2014 Year 05 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
2009 Year 12 Month 03 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003450

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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