Esophageal CancerPhase 1/2NCT00544362
Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
A Phase 1/2 study testing cetuximab, cisplatin and fluorouracil in people with Esophageal Cancer, run by Federation Francophone de Cancerologie Digestive at 13 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- cetuximab, cisplatin and fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 13 sitesFrance
- Study dates
- Jul 2007to Mar 2013
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus
- Invasive disease
- Only Siewert type I gastroesophageal carcinoma allowed
- Resectable disease
- T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III)
- No visceral metastases or mediastinal extensions compromising resectability
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- WHO performance status 0-1
- Weight loss < 15%
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Creatinine ≤ 1.25 times upper limit of normal
- PTT ≥ 80%
- Albumin ≥ 35 g/L
- FEV1 > 1 L
- Not pregnant or nursing
- Fertile patients of must use effective contraception
Who cannot join
- Inoperable disease
- Invasion of the tracheo-bronchial tree
- Recurring esophageal paralysis
- Esopho-tracheal fistula
- Cervical esophageal carcinoma (< 19 cm above the dental arches)
- Multifocal esophageal carcinoma
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- Superficial esophageal carcinoma (T1N0)
- Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected
- Proven metastatic disease
- PATIENT CHARACTERISTICS:
- Known liver cirrhosis
- Renal insufficiency
- Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence)
- Progressive coronary insufficiency
- Myocardial infarction in the past 6 months
- Legally incapacitated
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Noncompliant within constraints of the study
- Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years
- PRIOR CONCURRENT THERAPY:
- Prior anticancer chemotherapy or radiotherapy
- Treatment with endoprosthesis
- Surgery (esophagectomy) planned without thoracotomy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
Hopital Saint Andre
Bordeaux, 33075
C.H.U. de Brest
Brest, 29200
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, 63058
Hopital Du Bocage
Dijon, 21034
Federation Francophone de Cancerologie Digestive
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Hospital Universitaire Hop Huriez
Lille, 59037
CHU de la Timone
Marseille, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Regional de Purpan
Toulouse, 31059
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of fluorouracil and cisplatin when administered with cetuximab concurrently with esophageal radiotherapy. (Phase I)
- To determine the complete histological response rate (after surgical resection). (Phase II)
Secondary
- To determine progression-free survival and overall survival. (Phase II)
- To determine the rate of resection with negative margins (R0). (Phase II)
- To determine the overall tolerance to neoadjuvant therapy. (Phase II)
- To determine the postoperative morbidity and mortality. (Phase II)
OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and fluorouracil.
Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.
After completion of study therapy, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 2 years.
- Conditions
- Esophageal Cancer
- Being tested
- cetuximab, cisplatin, fluorouracil, conventional surgery
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
cisplatinDrug
fluorouracilDrug
conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Experimental | Weekly cetuximab (400 mg/m2 one week before start of radiotherapy RT and 250 mg/m2 during radiotherapyRT), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin CDDP (40 mg/m2 D1) on week 1 and 5 Receives: Biological: cetuximab; Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histologic response
Measured: After Surgery
Tolerance to neoadjuvant therapy
Measured: From Inclusion
Secondary outcomes (2)
Progression-free and overall survival
Measured: From inclusion
Mortality
Measured: From Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Schneider, Study chair, Federation Francophone de Cancerologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544362
- Sponsor's protocol ID
- CDR0000564075
- Other IDs
- FFCD-0505, EU-20756, EUDRACT-2006-004770-27, MERCK-FFCD-0505
- Status last verified
- May 2016
- First submitted
- 13 Oct 2007
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
- ClinicalTrials.gov ID
- NCT00544362
- Acronym / sponsor ID
- CDR0000564075
- Conditions
- Esophageal Cancer
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Oct 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of fluorouracil and cisplatin when administered with cetuximab concurrently with esophageal radiotherapy. (Phase I)
- To determine the complete histological response rate (after surgical resection). (Phase II)
Secondary
- To determine progression-free survival and overall survival. (Phase II)
- To determine the rate of resection with negative margins (R0). (Phase II)
- To determine the overall tolerance to neoadjuvant therapy. (Phase II)
- To determine the postoperative morbidity and mortality. (Phase II)
OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and fluorouracil.
Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.
After completion of study therapy, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Experimental | Biological: cetuximab, Drug: cisplatin, Drug: fluorouracil, Procedure: conventional surgeryWeekly cetuximab (400 mg/m2 one week before start of radiotherapy RT and 250 mg/m2 during radiotherapyRT), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin CDDP (40 mg/m2 D1) on week 1 and 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus
- Resectable disease
- WHO performance status 0-1
- Weight loss < 15%
- Absolute neutrophil count ≥ 1,500/mm3
Key exclusion criteria (23 listed)
- Inoperable disease
- Invasion of the tracheo-bronchial tree
- Recurring esophageal paralysis
- Esopho-tracheal fistula
- Cervical esophageal carcinoma (< 19 cm above the dental arches)
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 | Biological | Neoadjuvant chemoradiotherapy |
| cisplatin | Drug | Neoadjuvant chemoradiotherapy |
| fluorouracil | Drug | Neoadjuvant chemoradiotherapy |
| conventional surgery | Procedure or surgery | Neoadjuvant chemoradiotherapy |
Primary outcome
Complete histologic response
Time frame: After Surgery
Tolerance to neoadjuvant therapy
Time frame: From Inclusion
2 secondary outcomes
Progression-free and overall survival
Time frame: From inclusion
Mortality
Time frame: From Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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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.
Martina Schneider study chair
Federation Francophone de Cancerologie Digestive
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cetuximab, cisplatin and fluorouracil in people with Esophageal Cancer, run by Federation Francophone de Cancerologie Digestive at 13 sites in France.
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 16 inclusion and 23 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: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete histologic response (time frame: After Surgery). The study lists 2 primary outcomes in all. 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 30 May 2016.