UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003634
Receipt number R000004403
Scientific Title Phase I Study of definitive chemoradiotherapy with Docetaxel, CDDP and 5-FU for Unresectable or Recurrent Esophageal Cancer
Date of disclosure of the study information 2010/05/18
Last modified on 2018/11/25 09:43:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I Study of definitive chemoradiotherapy
with Docetaxel, CDDP and 5-FU
for Unresectable or Recurrent Esophageal Cancer

Acronym

Phase I Study of definitive chemoradiotherapy
with Docetaxel, CDDP and 5-FU
for Unresectable or Recurrent Esophageal Cancer

Scientific Title

Phase I Study of definitive chemoradiotherapy
with Docetaxel, CDDP and 5-FU
for Unresectable or Recurrent Esophageal Cancer

Scientific Title:Acronym

Phase I Study of definitive chemoradiotherapy
with Docetaxel, CDDP and 5-FU
for Unresectable or Recurrent Esophageal Cancer

Region

Japan


Condition

Condition

advanced or recurrence esophageal carcinoma

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerated dose and the recommended dose of chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil for advanved or recurrent esophageal carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

to estimate the mazimum tolerated dose and the recommendeddose

Key secondary outcomes

adverse events, response rate, overall sirvival, progression free survival


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

Patients receive an infusion of docetaxel (50, 60 or 70mg/m2) on days 1, 22 and an infusion of cisplatin (10 mg/m2) plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5 and 22-26. And patients receive 60 Gy/30 fractions of concurrent radiotherapy.

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 squamous cell carcinoma of esophagus.
2. clinically confirmed T4 tumor and/or M1 LYM or M1 according to the Tumor-Node-Metastasis classification of the UICC, or recurrent esophageal carcinoma after radical esophagectomy
3. There is at least one estimative lesion.
4. Patients have never received chemoradiotherapy or radiotherapy for esophageal cancer.
5. Patients of age =>20 and 75=> at the registration.
6. Performance Status:0-2(ECOG)
7. Sufficient organ functions within two weeks before registration.
1) leukocyte >=4,000/mm3 and <=12,000/mm3
2) platelets >=100,000/mm3
3) hemoglobin >=9.0g/dl (and except from administration of blood transfusion)
4) total bilirubin <=1.5mg/dl
5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal
6) total bilirubin <=1.5 mg/dl
7) creatinine clearance >=60ml/min (following Cockcroft-Gault calculus
8) SpO2 >= 95%(at room air)
8. Written informed consent.
9. It is expected that patients survive for over 3 months.

Key exclusion criteria

1. Patients have serious complications (heart disease, pulmonary fibrosis, interstitial pneumonia, hemorrhagic tendency and so on)
2. active infection
3. active synchronous malignancy
4. esophagotracheal or esophagobronchial fistulas
5. peripheral neuropathy or edema >= Grade 2 (CTCAE version3)
6. history of serious drug hypersensitivity
7. brain metastasis
8. pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy
9. patients who are judged inappropriate for the entry into study by the investigator

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Doki

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, 565-0871

TEL

06-6879-3251

Email

ydoki@gesurg.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Yamasaki

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, 565-0871

TEL

0668793251

Homepage URL


Email

myamasaki@gesurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Surgery, Graduate School of Medicine, Osaka University

Institute

Department

Personal name



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

大阪大学病院(大阪府)、彩都友紘会病院(大阪府)


Other administrative information

Date of disclosure of the study information

2010 Year 05 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially 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

No longer recruiting

Date of protocol fixation

2009 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2013 Year 04 Month 01 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 05 Month 01 Day

Date analysis concluded

2013 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 05 Month 18 Day

Last modified on

2018 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004403


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name