Study of S-1 in Combination With Radiotherapy in Esophage... | NCT01831531

Studies
Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

NCT01831531

Sponsor

Fudan University

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

105Actual

Phase

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S-1
Radiation therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

Oct 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Apr 11, 2013

First Submission Date that Met QC Criteria

Apr 11, 2013

First Posted Date

Apr 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S-1	Experimental	Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy	Drug: S-1 Radiation: Radiation therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-1	Drug	S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28	S-1

Measure	Description	Time Frame
Number of participants with adverse events		1 years
3-yr local control rate		3 years

Measure	Description	Time Frame
Overall survival		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Joined the study voluntarily and signed informed consent form;
Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
Both genders
Esophageal squamous cell carcinoma confirmed by pathology
Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
No radiotherapy, chemotherapy or other treatments prior to enrollment
PS ECOG 0-2
Life expectancy of more than 3 months
Hemoglobin（Hb）≥9 g/dL
WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
platelet count (Pt) ≥100x 109/L
Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
Renal function: creatinine < 1.5 x ULN
No immuno-deficiency
Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

Complete esophageal obstruction
Deep esophageal ulcer
Esophageal perforation
Haematemesis
After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
Participation in other interventional clinical trials within 30 days
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Drug addiction
Alcoholism or AIDS
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
Patient who has metastasis such as lung, liver metastasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kuaile Zhao, M.D.	Fudan University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Center		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35449578	Derived	Chen Y, Zhu Z, Zhao W, Liu Q, Zhang J, Deng J, Ai D, Lu S, Jiang L, Tseng I, Jia H, Zhao K. Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities. Front Oncol. 2022 Apr 5;12:839765. doi: 10.3389/fonc.2022.839765. eCollection 2022.

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
C079198	S 1 (combination)
D011878	Radiotherapy