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

NCT02636088 | Unknown Phase 2

• 1 other identifier: 2008-006802-40
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Neoplasm

Keywords

Phase II study, clinical trial

Outcome Measures

Primary Outcomes (1)

• Local tumour Control

  Local tumour control will be measured with a computed tomography

  1 year

Secondary Outcomes (5)

• Progression-free survival

  3 years

• Toxicity

  3 years

• Patterns of relapse

  3 years

• Overall and disease-free survival

  3 years

• Quality of life

  3 years

Study Arms (1)

Cetuximab

EXPERIMENTAL

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.

Drug: Cetuximab

Interventions

Cetuximab DRUG

Cetuximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gabriella Alexandersson von Döbeln: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gabriella A von Döbeln, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: September 21, 2018

Record last verified: 2018-09