CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 181 enrolled
Drug / intervention
Chemotherapy +1 moredrug
Likely dose
Chemotherapy 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01362127
NCT01362127Phase 2Completed
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Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy

Karolinska University Hospital·interventional·Posted May 27, 2011·Updated Feb 26, 2020

In Brief

A Phase 2 clinical trial evaluating Chemotherapy and Radiochemotherapy for Carcinoma, Squamous Cell and Adenocarcinoma of the Esophagus and Gastric Cardia. Completed, enrolled 181 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell, Adenocarcinoma of the Esophagus and Gastric Cardia
CountriesSweden
CollaboratorsUniversity Hospital, Umeå, Region Örebro County, Sahlgrenska University Hospital, Ullevaal University Hospital, Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital, Malarhospital Eskilstuna

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 27, 2011
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2013
Study CompletionJun 25, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 15.1 years ago

Interventions

Chemotherapydrug

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.

Radiochemotherapyradiation

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.