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

Esophageal Neoplasm Clinical Trial

— LERFOX-C  

Official title:

A Phase II Study With Oxaliplatin + 5-FU + Ceuximab and Radiotherapy for the Treatment of Non-resectable, Locally Advanced But Not Metastatic Cancer of Oesophagus or the Cardia.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02636088
• Other study ID #: 2008-006802-40
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: January 2019

Study information

• Verified date: September 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Drug:
• Cetuximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gabriella Alexandersson von Döbeln

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumour Control	Local tumour control will be measured with a computed tomography	1 year
Secondary	Progression-free survival	Tumour respons evaluation with CT-scan	3 years
Secondary	Toxicity	Toxicity will be measured with the Common Toxicity Criteria Scale	3 years
Secondary	Patterns of relapse	First site of recurrence will be evaluated with CT, supplemented with biopsy if indicated	3 years
Secondary	Overall and disease-free survival	Tumour respons evaluation with CT scan	3 years
Secondary	Quality of life	Quality of life assessed with the EORTC QLQ-C30 questionnaire.	3 years