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

Sponsor

Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT01831531

Collaborator

(none)

105

Enrollment

Location

Arm

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: S-1 Radiation: Radiation therapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-1 Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy	Drug: S-1 S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28 Radiation: Radiation therapy 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.

Arm

Intervention/Treatment

Experimental: S-1

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

Drug: S-1

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

Radiation: Radiation therapy

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.

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [1 years]
3-yr local control rate [3 years]

Secondary Outcome Measures

Overall survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator: Kuaile Zhao, M.D., Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kuai Le Zhao, MD, Professor of Radiation Oncology, Fudan University

ClinicalTrials.gov Identifier:

NCT01831531

Other Study ID Numbers:

ESO-Shanghai7

First Posted:

Apr 15, 2013

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of Feb 15, 2019