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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006208
Receipt No. R000007340
Scientific Title Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Date of disclosure of the study information 2011/08/22
Last modified on 2011/08/21

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Basic information
Public title Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Acronym Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Scientific Title Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Scientific Title:Acronym Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Region
Japan

Condition
Condition Locally advanced rectal cancer with preoperative diagnosis of T3-4 and N0-3.
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the maximum tolerated dose (MTD) and recommended dose (RD) of irinotecan combined with preoperative chemoradiotherapy withUFT/Leucovorin in patients with locally advanced rectal cancer and to assess the histopathological effects as a primary end point.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes MTD and RD are determined by step 1. Histopathological effects are primary endpoints of step 2.
Key secondary outcomes Ratio of downstaging, rate of local recurrence, disease free survival and occurrence of adverse events are secondary outcomes of step 2.

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 28days. The total dose of radiation will be 50.4 Gy..
UFT (300 mg/m2/day) and Leucovorin (75mg/body/day) will be given orally three times per day on Days 1–5, 8–12, 22–26, and 29–33. Irinotecan will be given as a continuous i.v. infusion for 90 min on Days 1, 15, 29, and 43. The initial dose of Irinotecan was 50 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.
Radical surgery will be performed at least 6 weeks after the completion of 6 weeks of neoadjuvant chemoradiotherapy.
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. Previously untreated locally advanced lower rectal cancer with preoperative diagnosis of T3/4 and N0-3 and M0.
2. Histopathologically confirmed as adenocarcinoma before surgery.
3. No disturbance of main organ functions ( including bone marrow, heart, lung, liver and kidney)
3-1. Leukocyte count.: >=4,000/mm3 and <=12,000/mm3
3-2. Neutrophil count.: >=2,000/mm3
3-3. Platelet count.: >=100,000/mm3
3-4. Hemoglobin concentration.: >=9.0 g/dl.
3-5. Total bilirubin concentration.: <=1.5 mg/dl
3-6. Serum AST(GOT) and ALT(GPT) .: less than twice the upper limit of the normal at our hospital.
3-7. Serum creatinine concentration. less than upper limit of the normal at our hospital
4. Ability to ingestion intake and drug administration orally.
5. Performance status (ECOG): 0-1
6. Informed consent is obtained.

Key exclusion criteria 1. Allergic to a drug
2. Contraindications to UFT, Leucovorin and Irinotecan
3. Active infection
4. UGT1A: *6/*6, *28/*28 and *6/*28
5. Severe complications such as ileus, interstitial pneumonia, DM, heart failure, lung failure and liver failure
6. Pregnant or planning to get pregnant.
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name EIJI SUNAMI
Organization The University of Tokyo Hospital
Division name Department of surgical oncology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo Hospit
Division name Department of surgical oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The University of Tokyo Hospital.
Department of surgical oncology.
Institute
Department

Funding Source
Organization none
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
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
2011 Year 08 Month 22 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
2011 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
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
2011 Year 08 Month 21 Day
Last modified on
2011 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007340

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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