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Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

NCT01362127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2020-02-26

Study results available
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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

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.

Sponsors & Collaborators

  • University Hospital, Umeå

    collaborator OTHER

  • Region Örebro County

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Ullevaal University Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Malarhospital Eskilstuna

    collaborator UNKNOWN

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Magnus Nilsson, Professor · Karolinska University Hospital, Gastrocentrum

  • Lars Lundell, Professor · Karolinska University Hospital, Gastrocentrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2013-06-30
Completion
2018-06-25

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362127 on ClinicalTrials.gov