UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015530
Receipt number R000018039
Scientific Title A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Date of disclosure of the study information 2014/12/01
Last modified on 2018/11/21 14:02:59

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Basic information

Public title

A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer

Acronym

Preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer

Scientific Title

A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer

Scientific Title:Acronym

Preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer

Region

Japan


Condition

Condition

locally advanced rectal cancer (T3-4, N0-2, M0)

Classification by specialty

Gastroenterology Surgery in general Gastrointestinal surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safet and efficacy of preoperative chemoradiation therapy with S-1 (2 weeks administration and 1 week withdrawal) for locally advanced rectal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

safety (incidence and grades of adverse events for preoperative chemoradiation therapy)

Key secondary outcomes

RFS, OS, accumulated local recurrence rate, treatment completion rate, R0 resection rate, down-stagingrate, pathological response rate, response rate (RECIST version1.1), pCR, nutritional assessment, immunohistochemical assessment, safety (operative complications, late adverse events).


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

S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks.
Radiationa therapy: 1.8 Gy/day, 5 days/week (through Monday to Friday), a total of 45 Gy/5 weeks.

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) Pathologically diagnosed as adenocarcinoma.
2) Patients who satisfy the following criteria within 28 days before registration:
* Patients with tumors in T3-4 and N0-2 according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition and resectable.
* The tumor is mainly located in Ra, Rb or P according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition.
* The anal margin of the tumor is lower than the level of peritoneal inversion.
* The tumor is not macroscopically classified into type 4.
* Diagnosed with colonoscopy, barium enema, contrast CT and contrast MRI. If the patient is allergic to contrast, plain CT and MRI are allowed.
* The distance between anal verge and the lower margin of the tumor should be recorded.
3) patients should be free from liver metastasis, peritoneal dissemination or distant metastasis.
4) Between 20 years old and 80 years old when registered.
5) Performance Status (ECOG) is 0-1.
6) No prior radiotherapy, chemotherapy or hormone therapy.
7) No severe disorder of bone marrow, heart, lung, liver or kidney. The data of blood test within 14 days before registration should be within the following range:
WBC counts: 12,000/mm3 > and > 3,000 /mm3
Neutrophil counts: > 1,500 / mm3
Platelet counts: > 75,000 /mm3
Hemoglobin: > 9.0 g/dl
Total bilirubin: 1.5 mg/dl >
AST (GOT), ALT (GPT): 80 IU/L >
Serum creatinine: 1.5 mg/dL >
Creatinine clearance: > 50 ml/min (with Cockcroft-Gault's formula)
8) No clinically abnormal finding of ECG within 28 days before registration
9) Patients who can eat food and can be orally administered.
10) Informed consent has been acquired.

Key exclusion criteria

1) Patients with past history of severe drug allergy.
2) Patients with active cancers in other organs or multicentric cancers in colorectum.
3) Contraindication of S-1 administration.
4) Patients who suffered from infection with fever higher than 38 degree.
5) Patients with severe complications such as bowel obstruction, ileus, intestinal pneumonitis or pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver dysfunction and others.
6) Patients with past history of intestinal pneumonitis.
7) Patients with pleural or ascites retention which should be treated.
8) Patients with fresh bleeding from intestinal tract.
9) Patients with watery diarrhea.
10) Women who are willing to pregnancy or possible to be pregnant. Patients who do not intend to prevent pregnancy.
11) Patients who are continuing steroid administration orally or intravenously.
12) Patients with HBs positive.
13) Patients whom doctors consider not to be eligible for this study for some other reasons.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koh Miura

Organization

Miyagi Cancer Center

Division name

Department of Surgery

Zip code


Address

47-1 Nodayama, Natori, Miyagi 981-1293, Japan

TEL

+81-22-384-3151

Email

kou-miura@miyagi-pho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koh Miura

Organization

Miyagi Cancer Center

Division name

Department of Surgery

Zip code


Address

47-1 Nodayama, Natori, Miyagi 981-1293, Japan

TEL

+81-22-384-3151

Homepage URL


Email

kou-miura@miyagi-pho.jp


Sponsor or person

Institute

Department of Surgery, Miyagi Cancer Center

Institute

Department

Personal name



Funding Source

Organization

None.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

None.


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

宮城県立がんセンター


Other administrative information

Date of disclosure of the study information

2014 Year 12 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

Completed

Date of protocol fixation

2014 Year 08 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 26 Day

Last modified on

2018 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018039


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name