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Search / Trial NCT01362127

Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

Launched by KAROLINSKA UNIVERSITY HOSPITAL · May 26, 2011

Trial Information

Current as of July 21, 2025

Completed

Keywords

Histologically Confirmed Squamos Cell Carcinoma Or Adenocarcinoma Of The Esophagus And Gastric Cardia.Suitable For Surgery.

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
  • Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
  • Adequate haemotological function, defined as having WBC \> 3 x 10(9)/litre and platelets \> 100 x 10 (9)/litre.
  • Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate \> 60 ml/min.
  • Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a
  • Exclusion Criteria:
  • Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
  • Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
  • Concomitant malignancy (\< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
  • Patients being unable tom comply with the protocol
  • Tumor stage T1 N0, T4 NX or TXNXM1b

About Karolinska University Hospital

Karolinska University Hospital is a leading academic medical center in Sweden, renowned for its commitment to advanced healthcare research and innovative clinical practices. As a key sponsor of clinical trials, the hospital leverages its extensive expertise in medical research and collaboration with Karolinska Institutet, one of the world's foremost medical universities. The institution is dedicated to enhancing patient care through rigorous scientific investigation, focusing on a wide range of therapeutic areas. With a multidisciplinary approach and a strong emphasis on translational medicine, Karolinska University Hospital aims to bridge the gap between laboratory findings and clinical application, ultimately striving to improve health outcomes and advance medical knowledge.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Magnus Nilsson, Professor

Principal Investigator

Karolinska University Hospital, Gastrocentrum

Lars Lundell, Professor

Study Chair

Karolinska University Hospital, Gastrocentrum

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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