Overview

This trial is active, not recruiting.

Conditions carcinoma, squamous cell, adenocarcinoma of the esophagus and gastric cardia
Treatments chemotherapy, radiochemotherapy
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiochemotherapy + Surgery
radiochemotherapy Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
(Active Comparator)
Chemotherapy + surgery
chemotherapy Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
radiochemotherapy Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
To evaluate the safety of respective neoadjuvant therapies.
time frame: Three years follow up

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.