Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
This trial is active, not recruiting.
|Conditions||carcinoma, squamous cell, adenocarcinoma of the esophagus and gastric cardia|
|Sponsor||Karolinska University Hospital|
|Collaborator||University Hospital, Umeå|
|Start date||October 2006|
|End date||March 2018|
|Trial size||180 participants|
|Trial identifier||NCT01362127, 2006-001785-16, EU-nr 2006-001785-16|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
To evaluate whether radiochemotherapy gives higher complete histological response (pCR) after resection than chemotherapy alone in patients with resectable carcinoma of the esophagus and cardia.
time frame: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
To evaluate the safety of respective neoadjuvant therapies.
time frame: Three years follow up
Male or female participants from 18 years up to 75 years old.
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
|Official title||Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy|
|Principal investigator||Lars Lundell, Professor|
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