Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Summary

So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.

Eligibility

Inclusion Criteria:

* Indicates no limit on eligibility based on the sex of participants
* The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
* Esophageal squamous cell carcinoma confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
* Use of an effective contraceptive for adults to prevent pregnancy
* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
* No immunodeficiency
* ECOG 0-1.
* Life expectancy of more than 3 months.

Exclusion Criteria:

* Total radiotherapy dose cannot reach 61.2Gy/34Fx
* Esophageal perforation, or hematemesis
* History of radiotherapy or chemotherapy for esophageal cancer
* History of surgery within 28 days before Day 1
* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or fertile patients
* Drug addiction,
* alcoholism or AIDS
* Uncontrolled seizures or psychiatric disorders

Conditions4

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