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Clinical Trials in China / NCT04519905
Recruiting Not applicable

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

NCT04519905 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Not applicable
Started
2020-01-06
Last updated
2021-11-02

Condition(s) studied

Esophageal Squamous Cell CarcinomaChemoradiotherapySurvival

Investigational drug(s) / intervention(s)

Paclitaxel plus carboplatinradiotherapy

Paclitaxel plus carboplatin: Paclitaxel (45mg/m2) plus carboplatin (AUC=2); five cycles; qw

radiotherapy: Different radiotherapy dose in different groups.

Study 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

Sex
ALL
Min age
76 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Jiangsu Cancer Hospital Nanjing Jiangsu Recruiting
Huadong Hospital Shanghai Shanghai Municipality Recruiting
Fudan Universtiy Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04519905 on ClinicalTrials.gov ↗ ← All trials in China