Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia (NeoRes)

Karolinska University Hospital

Status and phase: Completed; Phase 2

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

Treatments: Radiation: Radiochemotherapy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01362127

EU-nr 2006-001785-16

2006-001785-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 181 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

Radiochemotherapy

Active Comparator group

Description:

Arm I: Radiochemotherapy + Surgery

Treatment:

Drug: Chemotherapy

Radiation: Radiochemotherapy

Chemotherapy

Active Comparator group

Description:

Arm II: Chemotherapy + surgery

Treatment:

Drug: Chemotherapy