UMIN-CTR Clinical Trial

Public title

A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

Acronym

A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

Scientific Title

A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

Scientific Title:Acronym

A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

Region

Japan

Condition

esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The effectiveness and feasibility of preoperative DCF for the resectable advanced esophageal cancer are to be studied comparing those of preoperative FAP in a phase ll randomized trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Recurrence free survival

Key secondary outcomes

Rate of R0 resection
Complications of surgery
Overall survival
Adverse events
Response rates

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients are stratified by the number of metastatic lymph node and the institute at the registration.
Group A : FAP
CDDP70mg/m2(day1) ADM35mg/m2(day1), and 5-FU700mg/m2(day1-7) following 3 week rest
This treatment is to be done in two courses.
Patients undergo surgical operation (esophageal resection with D2 lymph node dissection) in 3-6 weeks after chemotherapy.

Interventions/Control_2

Group B : DCF
Docetaxel70mg/m2(day1) CDDP70mg/m2(day1), and 5-FU700mg/m2(day1-5) following 2 week rest
This treatment is to be done in two courses.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Thoratic esophageal cancer proven squamous cell carcinoma histologically
2.cT1-4a without any distant metastasis (eligible if only with supraclavicular lymph node tumor)
3.patients older than 20 y.o.
4.PS(ECOG) : 0,1 or 2
5.without any prior chemotherapy for esophageal cancer
6.with good organ functions :
WBC : 3,000/mm3 <= and >= 12,000/mm3
Neutrophile : 1,500/mm3 <=
Hemoglobin : 9.0g/dl <=
Platelet : 100,000/mm3 <=
T.bil. : under one and a half time of normal limit
AST,ALT : under two times of normal limit
Creatinine clearance : >=60 (Eligeble in direct method or Cockcroft-Gault method)
SpO2 >= 95% in room air
7.with written Informed Consent

Key exclusion criteria

1.Unresectable due to severe organ dysfunction (brain, heart, lung, liver, and/or kidney)
2.With active double cancers
3.With the history of severe drug allergy
4.Pregnant and/or nursing women, or women who expect to be pregnant
5.Patients whom doctor in chief decides not to register to this study

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Yuichirou Toki

Organization

Osaka University Graduate School of Medicine

Division name

surgical medicen course

Zip code

Address

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

TEL

06-6879-3251

Email

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

Name of contact person

1st name
Middle name
Last name	Hiroshi Furukawa

Organization

Kinki University School of Medicine

Division name

Department of surgery

Zip code

Address

377-2, Onohigashi, Osakasayama, Osaka, Japan

TEL

072-366-0221

Homepage URL

Email

hiroshi.furukawa@tokushukai.jp

Institute

OGSG

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

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

大阪大学(大阪府)、近畿大学(大阪府)、大阪成人病センター(大阪府)、大阪医療センター(大阪府)、近畿中央病院(兵庫県)、大阪府立急性期・総合医療センター(大阪府)、関西労災病院(兵庫県)、大阪医科大学(大阪府)、大阪厚生年金病院(大阪府)、NTT西日本大阪病院(大阪府)

Date of disclosure of the study information

2010

Year

12

Month

01

Day

URL releasing protocol

https://www.annalsofoncology.org/article/S0923-7534(19)31912-X/fulltext

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1002/ags3.12388

Number of participants that the trial has enrolled

162

Results

The R0 resection rates for the ACF and DCF groups were equivalent. The 2-year RFS significantly better in the DCF group than in the ACF group (64.1% vs 42.9% HR:0.53, 95%CI:0.33-0.83, P=0.0057) and OS rates were 78.6% versus 65.4% (P=0.08).

The 5-year RFS and the 5-year OS was significantly better in the DCF group than in the ACF group (59.9% vs 40.7%, HR:0.55; 95%CI:0.35-0.86; P=0.009) and (63.5% vs 49.4%, HR:0.61; 95% CI:0.38-0.96; P=0.03) respectively.

Results date posted

2020

Year

01

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2016

Year

09

Month

29

Day

Baseline Characteristics

patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC)

Participant flow

Between October 2011 and October 2013, 162 patients at 10 institutions were enrolled in the study, 162 of whom were eligible and randomly assigned to the two groups, followed by surgery.

Adverse events

.

Outcome measures

https://www.annalsofoncology.org/article/S0923-7534(19)31912-X/fulltext
The R0 resection rates for the ACF and DCF groups were equivalent (95.9% versus 96.2%, P=0.93). The 2-year RFS and overall survival rates for DCF versus ACF were 64.1% versus 42.9% (hazard ratio 0.53, 95% confidence interval 0.33-0.83, P=0.0057) and 78.6% versus 65.4% (P=0.08), respectively.
https://onlinelibrary.wiley.com/doi/10.1002/ags3.12388
The 5-year RFS was significantly better in the DCF group than in the ACF group (59.9% vs 40.7%, hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.35-0.86; =0.009) and the 5-year OS was significantly better in the DCF group than in the ACF group (63.5% vs 49.4%, HR, 0.61; 95% CI, 0.38-0.96; P=0.03).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

11

Month

11

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

29

Day

Last follow-up date

2014

Year

10

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2014

Year

12

Month

27

Day

Other related information

Registered date

2010

Year

11

Month

24

Day

Last modified on

2025

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005493