S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-08-31

Brief Summary

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This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.

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Detailed Description

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Conditions

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Esophageal Cancer Chemoradiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chemoradiotherapy

Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42

Group Type EXPERIMENTAL

Radiotherapy 54 Gy

Intervention Type RADIATION

Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.

S-1

Intervention Type DRUG

S-1 70mg/m2 was administered on days 1-14 and 29-42.

Radiotherapy 60 Gy

Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.

Group Type ACTIVE_COMPARATOR

Radiotherapy 60 Gy

Intervention Type RADIATION

Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.

Interventions

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Radiotherapy 54 Gy

Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.

Intervention Type RADIATION

Radiotherapy 60 Gy

Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.

Intervention Type RADIATION

S-1

S-1 70mg/m2 was administered on days 1-14 and 29-42.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological or cytologic diagnosis of esophageal carcinoma
* ECOG performance status 0-1
* Age:70-85 years
* Joined the study voluntarily and signed informed consent form
* Patients must not have received any prior anticancer therapy
* Stage Ⅰ-ⅣB（AJCC 2009）
* Target lesions can be measured according to RECIST criteria
* No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN

Exclusion Criteria

* Multiple carcinomas of the esophagus,
* Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
* Metastatic disease (M1b),
* A primary tumor that extended to within 2 cm of the gastroesophageal junction,
* Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
* history of a second malignancy other than nonmelanoma skin cancer

Minimum Eligible Age

70 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No