drugset / Trial / NCT00193882

Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.

NCT00193882 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.

Timeline

Start
2003-07-07
Primary completion
2012-03-21
Completion
2013-06-18

Outcome

Missed primary endpoint

paper Palliative chemoradiotherapy showed a modest, but not statistically significant, increase in dysphagia relief compared with radiotherapy alone PMID 29248399 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject fluorouracil Small molecule 800 mg/m2 Intravenous

Indications