Definitive Chemoradiotherapy and Cetuximab in the Treatment of Locally Advanced Esophageal Cancer

NCT ID: NCT02636088

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2019-01-31

Brief Summary

In patients with esophageal cancer, treatment with curative intent can be given to medically fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone or in combination. Surgery in combination with chemotherapy is another option. For patients who are not medically fit for surgery or with unresectable invasion in adjacent structures the only alternative with curative intent is, with current knowledge, definitive chemoradiotherapy. In the current study the investigators aim to improve prognosis for patients not suitable for surgery. Patients receive treatment with conventional chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more recently developed drug, an antibody called cetuximab.

Detailed Description

Patients are treated with three cycles of oxaliplatin and fluorouracil 750 mg/m2/24 hours, day 1-5. Each cycle lasts for 21 days. Oxaliplatin is given with 130 mg/m2 in the first cycle and in cycle 2 and 3 which are administered concomitant with radiotherapy the dose is reduced to 85 mg/m2.

A loading dose of cetuximab 400 mg/m2 is given one week before the start of radiotherapy, and thereafter 250 mg/m2 is given weekly during the course of radiotherapy.

Concomitant with chemotherapy radiotherapy to a total dose of 50 Gy is given (2 Gy once daily in 25 fractions, 5 days a week) with a photon beam linear accelerator.

After treatment patients are followed every 6 months for three years with clinical examination and a CT-scan.

Conditions

Esophageal Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab

Cetuximab is administered once a week. The initial dose is 400 mg/m2 body surface area. First Cetuximab infusion should start day 15 in cycle 1.The subsequent weekly doses are 250 mg/m2.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Interventions

Cetuximab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological verified squamos cell carcinoma or adenocarcinoma of the oesophagus or cardia
• Performance status WHO 0-2, age 18-75 years
• Locally advanced disease, non-resectable (T4 N0-N3 M0) or disease which is not operable for any other reason (T2/T3 N0-N3 M0)
• Adequate hematological, liver and renal function
• Written informed consent

Exclusion Criteria

• Distant metastases
• Prior chemotherapy or radiotherapy for oesophageal cancer or cancer of the cardia
• Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
• Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed consent
• Myocardial infarction within 6 months prior to study entry
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 2 years
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Accepts Healthy Volunteers: No

Sponsors

Gabriella Alexandersson von Döbeln

OTHER

Sponsor Role: lead

Responsible Party

Gabriella Alexandersson von Döbeln

Medical doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gabriella A von Döbeln, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Other Identifiers

2008-006802-40

Identifier Type: -

Identifier Source: org_study_id