Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

Phase 2

Completed

Conditions: Carcinoma, Squamous Cell
Adenocarcinoma of the Esophagus and Gastric Cardia

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Radiochemotherapy	Chemotherapy	Arm I: Radiochemotherapy + Surgery
Radiochemotherapy	Radiochemotherapy	Arm I: Radiochemotherapy + Surgery
Chemotherapy	Chemotherapy	Arm II: Chemotherapy + surgery

Primary Outcome Measures

Name	Time	Method
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.	Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.	Chireac tumour regression grade

Secondary Outcome Measures

Name	Time	Method
Safety of Respective Neoadjuvant Therapies.	Five years follow up	Safety profile of carrying out radical surgery after respective neoadjuvant therapy.
HRQOL and Swallowing Function	Entry study up to Five years follow up	The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question.