NCT01831531

Brief Summary

This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.6 years

First QC Date

April 11, 2013

Last Update Submit

February 14, 2019

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events

    1 years

  • 3-yr local control rate

    3 years

Secondary Outcomes (1)

  • Overall survival

    3 years

Study Arms (1)

S-1

EXPERIMENTAL

Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy

Drug: S-1Radiation: Radiation therapy

Interventions

S-1DRUG

S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA \>1.6 m2) p.o bid d1-28

S-1
Radiation therapyRADIATION

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

S-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 35449578DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kuaile Zhao, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiation Oncology

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CN(1)