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

U

University of Chinese Academy Sciences

Status and phase

Completed
Phase 3

Conditions

Esophageal Cancer
Chemoradiation

Treatments

Radiation: Radiotherapy 54 Gy
Drug: S-1
Radiation: Radiotherapy 60 Gy

Study type

Interventional

Funder types

Other

Identifiers

NCT02813967
ZJCH-E-E

Details and patient eligibility

About

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.

Enrollment

298 patients

Sex

All

Ages

70 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

298 participants in 2 patient groups

chemoradiotherapy
Experimental group
Description:
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
Treatment:
Radiation: Radiotherapy 54 Gy
Drug: S-1
Radiotherapy 60 Gy
Active Comparator group
Description:
Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
Treatment:
Radiation: Radiotherapy 60 Gy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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