Back to results

Definitive Chemoradiotherapy and Cetuximab in the Treatment of Locally Advanced Esophageal Cancer (LERFOX-C)

Primary Purpose

Esophageal Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cetuximab

About this trial

This is an interventional treatment trial for Esophageal Neoplasm focused on measuring Phase II study, clinical trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Local tumour Control

Local tumour control will be measured with a computed tomography

Secondary Outcome Measures

Progression-free survival

Tumour respons evaluation with CT-scan

Toxicity

Toxicity will be measured with the Common Toxicity Criteria Scale

Patterns of relapse

First site of recurrence will be evaluated with CT, supplemented with biopsy if indicated

Overall and disease-free survival

Tumour respons evaluation with CT scan

Quality of life

Quality of life assessed with the EORTC QLQ-C30 questionnaire.

Full Information

NCT ID

NCT02636088

First Posted

December 15, 2015

Last Updated

September 20, 2018

Sponsor

Gabriella Alexandersson von Döbeln

1. Study Identification

Unique Protocol Identification Number

NCT02636088

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gabriella Alexandersson von Döbeln

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasm

Keywords

Phase II study, clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Primary Outcome Measure Information:

Title

Local tumour Control

Description

Local tumour control will be measured with a computed tomography

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Tumour respons evaluation with CT-scan

Time Frame

3 years

Title

Toxicity

Description

Toxicity will be measured with the Common Toxicity Criteria Scale

Time Frame

3 years

Title

Patterns of relapse

Description

First site of recurrence will be evaluated with CT, supplemented with biopsy if indicated

Time Frame

3 years

Title

Overall and disease-free survival

Description

Tumour respons evaluation with CT scan

Time Frame

3 years

Title

Quality of life

Description

Quality of life assessed with the EORTC QLQ-C30 questionnaire.

Time Frame

3 years

10. Eligibility

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriella A von Döbeln, MD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs