UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004104 |
|---|---|
| Receipt number | R000004935 |
| Scientific Title | A phase II study of preoperative concurrent chemoradiation therapy for patients with locally advanced rectal cance |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2010/08/26 12:02:08 |
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Basic information
Public title
A phase II study of preoperative concurrent chemoradiation therapy for patients with locally advanced rectal cance
Acronym
Study of preoperative concurrent XELOX and radiation therapy for patients with locally advanced rectal cancer
Scientific Title
A phase II study of preoperative concurrent chemoradiation therapy for patients with locally advanced rectal cance
Scientific Title:Acronym
Study of preoperative concurrent XELOX and radiation therapy for patients with locally advanced rectal cancer
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate efficacy and safety of preoperative capecitabine/oxaliplatin with concurrent radiation therapy for patients with locally advanced rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological Complete Response Rate
Key secondary outcomes
Relapse Free Survival,
Overall Survival,
Overall Response Rate,
Early Complications,
late Complications,
Evaluation of safety
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)Capecitabine at a dose of 2,000mg/m2/day orally in 2 divided doses for 2weeks on and 1week rest
2) tri-Weekly oxaliplatin at a dose of 130mg/m2 intravenously
3) Radiotherapy is delivered a total irradiation dose of 45 Gy given in daily fractions of 1.8 Gy, 5 days a week
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed Rectum cancer
2. Preoperative findings T2-T4 by endscopic
3.Lower tumor margin is below at the Rb
4.Without prior anti-cancer therapy (chemotherapy,radiation therapy and endocrine therapy)
5. Over 20years old at IC
6. ECOG PS: 0 or 1
6. With or without target lesion by RECIST
7. Alife expectancy greater than 3 months
8.Adequate oral intake
9.Written IC
10. Adequate organ function within the last 14days
Key exclusion criteria
1. Prior or synchronous invasive malignancy unless disease free for a minimum of 5 years
2.Need to drain malignant coelomic fluid
3.Patients with infection requiring antibiotics and/or antifungal agents
4.Existing fever above 38 degrees centigrade
5.Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, heart failure, renal failure and hepatic failure)
6.Previous history of severe drug-induced allergy caused by capecitabine and/or oxaliplatin
7.History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines
8.Evidence of uncontrolled diarrhea
9.Evidence of diabetic mellitus which uncontrolled or treated with administration of insulin
10.Evidence of fistula
11.With distant metastases (M1)
12.Evidence of psychiatric disability interfering with enrollment to clinical trial
13.Need systemic administration of corticosteroids
14.Pregnant or lactating women,
women who are capable of pregnancy or intend to get pregnant
15.Patients judged inappropriate for this study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Nakamura |
Organization
Hamamatsu University School of Medicine
Division name
Second department of Surgery
Zip code
Address
20-1, 1-chome, Handayama, higashi-ku, Hamamatsu-city, Shizuoka-pref. Japan
TEL
053-435-2279
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Nakamura |
Organization
Hamamatsu University School of Medicine
Division name
Second department of Surgery
Zip code
Address
20-1, 1-chome, Handayama, higashi-ku, Hamamatsu-city, Shizuoka-pref. Japan
TEL
053-435-2279
Homepage URL
toshi38@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, Second department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine, Second department of Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwata city hospital and Fujinomiya city general hospital
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
浜松医科大学(静岡県）、磐田市立総合病院(静岡県）、富士宮市立病院(静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | 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
| 2010 | Year | 08 | Month | 26 | Day |
Last modified on
| 2010 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004935
