UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The University of Tokyo Hospital.
Department of surgical oncology.

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

08

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

08

Month

21

Day

Last modified on

2011

Year

08

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007340