Overview

Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

Status:
Completed
Trial end date:
2018-06-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karolinska University Hospital
Collaborators:
Haukeland University Hospital
Malarhospital Eskilstuna
Oslo University Hospital
Region Örebro County
Sahlgrenska University Hospital, Sweden
St. Olavs Hospital
Ullevaal University Hospital
University Hospital, Umeå
Treatments:
Carboplatin
Cisplatin
Oxaliplatin
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