Esophageal NeoplasmPhase 2LERFOX-CNCT02636088
Definitive Chemoradiotherapy and Cetuximab in the Treatment of Locally Advanced Esophageal Cancer
A Phase 2 study testing Cetuximab in people with Esophageal Neoplasm, run by Gabriella Alexandersson von Döbeln.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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.
Read the 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
- Being tested
- Cetuximab
- Keywords
- Phase II study, clinical trial
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumour Control
Local tumour control will be measured with a computed tomography
Measured: 1 year
Secondary outcomes (5)
Progression-free survival
Tumour respons evaluation with CT-scan
Measured: 3 years
Toxicity
Toxicity will be measured with the Common Toxicity Criteria Scale
Measured: 3 years
Patterns of relapse
First site of recurrence will be evaluated with CT, supplemented with biopsy if indicated
Measured: 3 years
Overall and disease-free survival
Tumour respons evaluation with CT scan
Measured: 3 years
Quality of life
Quality of life assessed with the EORTC QLQ-C30 questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriella Alexandersson von Döbeln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriella Alexandersson von Döbeln, Karolinska University Hospital
- Investigators
- Gabriella A von Döbeln, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636088
- Sponsor's protocol ID
- 2008-006802-40
- Other IDs
- 2008
- Acronym
- LERFOX-C
- Status last verified
- Sep 2018
- First submitted
- 15 Dec 2015
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02636088
- Acronym / sponsor ID
- LERFOX-C / 2008-006802-40
- Conditions
- Esophageal Neoplasm
- Keywords
- Phase II study, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Gabriella Alexandersson von DöbelnUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Experimental | Drug: CetuximabCetuximab 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. |
Who may qualify
- Ages
- 18 to 75 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab | Drug | Cetuximab |
Primary outcome
Local tumour Control
Time frame: 1 year
Local tumour control will be measured with a computed tomography
5 secondary outcomes
Progression-free survival
Time frame: 3 years
Toxicity
Time frame: 3 years
Patterns of relapse
Time frame: 3 years
Overall and disease-free survival
Time frame: 3 years
Quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella A von Döbeln, MD principal investigator
Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Esophageal Neoplasm, run by Gabriella Alexandersson von Döbeln.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumour Control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.