Head and Neck CancerPhase 2ECHO-07NCT00665392
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
A Phase 2 study testing cisplatin, docetaxel and fluorouracil in people with Head and Neck Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 sites in France.
Trial summary
RATIONALE: 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, docetaxel and fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Feb 2008to 1 Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- WHO performance status 0-1
- ANC ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
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- AST and ALT < 5 times ULN
- Bilirubin < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Affiliated with social security (including CMU)
Who cannot join
- Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
- Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
- Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
- Auditory condition precluding the use of cisplatin
- Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
- Persons under guardianship or trusteeship, or prisoners of law
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- PRIOR CONCURRENT THERAPY:
- No prior treatment, including chemotherapy or radiotherapy
- No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpital Simone Veil
Montmorency, 95160
Hôpital Privé St Joseph
Paris, 75014
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Bichat - Claude Bernard
Paris, 75018
Hopital Tenon
Paris, 75970
centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre René Huguenin
Saint-Cloud, 92100
Hopital Foch
Suresnes, 92151
About this study
Official title: Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.
Secondary
- To determine the rate of tumor response.
- To determine progression-free and overall survival.
- To determine the rate of complete pathological response.
- To assess the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months for 1 year and every 3 months for 2 years.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, docetaxel, fluorouracil, Cetuximab
- Keywords
- stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
75 mg/m², day 1. 3 cycles
docetaxelDrug
75 mg/m² Day 1. 3 cycles
fluorouracilDrug
750 mg/m² day 1 to day 5. 3 cycles
CetuximabDrug
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| cetuximab | Experimental | Cetuximab by intravenous (IV) infusion over 1-2 h on day Receives: Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
Measured: at 3 months after ETPF combination
Secondary outcomes (5)
Complete Clinical Response (cCR)
Clinical complete response (cCR) is defined by:
- Disappearance of all clinical evidence of visible tumor,
- Disappearance of all palpable residual infiltration,
- Disappearance of all evidence of residual visible tumor on CT scan in pharynx and parapharyngeal space,
- Complete symmetric remobilization of the tongue and amygdala.
- Disappearance of pre-existing trismus.
- Negative control biopsy.
The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
Measured: at 3 months
The 2-year Estimated Overall Survival (OS) Rate
2-year OS measured survival at 2 years from randomization.
Measured: 2 years
Pathologic Response
On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece
A pathological complete response is defined as no viable tumour cells detected on histological examination post surgery.
Measured: after surgery of the primary tumor
The 2-year Estimated Progression-free Survival (PFS)
2-year PFS measured survival at 2 years from randomization.
Measured: 2 years
Complete Radiological Response (rCR)
Radiological response is defined according to RECIST 1.0 criteria:
- Complete response (CR): disappearance of all target lesions
- Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter,
- Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target the appearance of one or more new lesions,
- Stable disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started
Measured: At 3 months after the end of 3 cycles of the ETPF combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study start1 Feb 2008
- Primary completion1 Feb 2012
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Lacau Saint Guily, MD, Principal investigator, Hopital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665392
- Sponsor's protocol ID
- CDR0000593027
- Other IDs
- GERCOR-ECHO-07-1, 2007-002116-25, EU-20838, MERCK-GERCOR-ECHO-07-1
- Acronym
- ECHO-07
- Status last verified
- Jul 2025
- First submitted
- 22 Apr 2008
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chibaudel B, Lacave R, Lefevre M, Soussan P, Antoine M, Perie S, Belloc JB, Banal A, Albert S, Chabolle F, Ceruse P, Baril P, Gatineau M, Housset M, Moukoko R, Benetkiewicz M, de Gramont A, Bonnetain F, Lacau St Guily J. Induction therapy with cetuximab plus docetaxel, cisplatin, and 5-fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCOR phase II ECHO-07 study. Cancer Med. 2015 May;4(5):721-31. doi: 10.1002/cam4.408. Epub 2015 Feb 14.
PubMed 25684313
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
- ClinicalTrials.gov ID
- NCT00665392
- Acronym / sponsor ID
- ECHO-07 / CDR0000593027
- Conditions
- Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 1 Feb 2008 (actual)
- Primary completion
- 1 Feb 2012 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.
Secondary
- To determine the rate of tumor response.
- To determine progression-free and overall survival.
- To determine the rate of complete pathological response.
- To assess the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months for 1 year and every 3 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 |
|---|---|---|
| cetuximab | Experimental | Drug: cisplatin, Drug: docetaxel, Drug: fluorouracil, Drug: CetuximabCetuximab by intravenous (IV) infusion over 1-2 h on day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- WHO performance status 0-1
- ANC ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
Key exclusion criteria (9 listed)
- Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
- Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
- Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
- Auditory condition precluding the use of cisplatin
- Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
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 |
|---|---|---|
| cisplatin75 mg/m², day 1. 3 cycles | Drug | cetuximab |
| docetaxel75 mg/m² Day 1. 3 cycles | Drug | cetuximab |
| fluorouracil750 mg/m² day 1 to day 5. 3 cycles | Drug | cetuximab |
| Cetuximab400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles. | Drug | cetuximab |
Primary outcome
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
Time frame: at 3 months after ETPF combination
The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
5 secondary outcomes
Complete Clinical Response (cCR)
Time frame: at 3 months
The 2-year Estimated Overall Survival (OS) Rate
Time frame: 2 years
Pathologic Response
Time frame: after surgery of the primary tumor
The 2-year Estimated Progression-free Survival (PFS)
Time frame: 2 years
Complete Radiological Response (rCR)
Time frame: At 3 months after the end of 3 cycles of the ETPF combination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25684313Chibaudel B, Lacave R, Lefevre M, Soussan P, Antoine M, Perie S, Belloc JB, Banal A, Albert S, Chabolle F, Ceruse P, Baril P, Gatineau M, Housset M, Moukoko R, Benetkiewicz M, de Gramont A, Bonnetain F, Lacau St Guily J. Induction therapy with cetuximab plus docetaxel, cisplatin, and 5-fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCOR phase II ECHO-07 study. Cancer Med. 2015 May;4(5):721-31. doi: 10.1002/cam4.408. Epub 2015 Feb 14.
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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.
Jean Lacau Saint Guily, MD principal investigator
Hopital Tenon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, docetaxel and fluorouracil in people with Head and Neck Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 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 11 inclusion and 9 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 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months (time frame: at 3 months after ETPF combination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665392, which also lists 1 linked publication.
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 1 Aug 2025.