NCT01362127

Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.

Conditions

• Carcinoma, Squamous Cell
• Adenocarcinoma of the Esophagus and Gastric Cardia

Interventions

Type	Name	Description
DRUG	Chemotherapy	Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
RADIATION	Radiochemotherapy	Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-06-01
• Completion: 2018-06-25
• First posted: 2011-05-27
• Last updated: 2020-02-26
• Results posted: 2020-02-26

Locations

1 site across 1 country: Sweden