Squamous Cell Carcinoma of the Head and NeckPhase 3INTERCEPTORNCT00999700
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
A Phase 3 study testing docetaxel - cisplatin - 5-fluorouracil, radiotherapy and cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Gruppo Oncologico del Nord-Ovest at 21 sites in Italy.
Trial summary
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- docetaxel - cisplatin - 5-fluorouracil, radiotherapy and cetuximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 21 sitesItaly
- Study dates
- Sep 2009to Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Histologically or cytologically confirmed diagnosis of HNSCC
- Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)
- At least one uni-dimensional measurable lesion either by CT scan or MRI
- Signed written informed consents prior to beginning protocol
- Specific procedures:
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- Tumor tissue available for immunohistochemical staining of EGFR expression and HPV
- Life expectancy of > 3 months at study entry
- ECOG Performance Status of <2 at study entry.
- Effective contraception if risk of conception exists.
- Neutrophils > 2.0/mm³, platelet count > 100,000/mm³, and hemoglobin > 10 g/dl
- Normal liver function
- Serum creatinine > 1.25 x ULN and/or creatinine clearance > 60 ml/min
Who cannot join
- Prior systemic chemotherapy and/or radiotherapy
- Known peripheral neuropathy > grade 2 NCI-CTC version 3.0
- Known chronic heart failure
- Prior surgery, excluding prior diagnostic biopsy
- Known drug abuse
- Active uncontrolled infection
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- Other concomitant anticancer therapy
- Distant metastasis
- Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol
- Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry
- Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
- Nasopharyngeal carcinoma WHO type II or III
- Known allergic reaction against any of the components of the treatment
- Pregnancy (absence confirmed by beta-HCG test) or lactation period
- Any prior or on-going investigational medication
- Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Ospedale Civile Ss. Antonio E Biagio
Alessandria
Ausl Della Valle D' Aosta
Aosta
Policlinico S. Orsola-Malpighi
Bologna
Asl 8 - Ospedale Businco
Cagliari
A.S.O. S. Croce E Carle
Cuneo, 12100
Irccs - Aou S. Martino - Oncology
Genoa
Irccs - Aou San Martino - Radiotherapy
Genoa
Asl 3 Genovese
Genova
E.O. Ospedali Galliera
Genova
Azienda Ospedaliera Villa Scassi - Asl3
Italy
Istituto Nazionale Dei Tumori
Milan
Azienda Ospedaliero Universitaria Di Modena
Modena
Ospedale S. Giacomo
Novi Ligure (al), Italy
Azienda Ospedaliero-Universitaria Di Parma
Parma
Azienda Ospedaliera Ospedali Riuniti Di Fano
Pesaro
Arcispedale S. Maria Nuova
Reggio Emilia
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture (pz), Italy
Ospedale S. Filippo Neri
Roma
Ospedale S. Paolo
Savona
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
Turin
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Turin
About this study
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
Read the detailed description
The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).
- Keywords
- Locally advanced HNSCC, Chemo-radiation, Induction chemotherapy, Stage III/IV, Unresectable disease
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel - cisplatin - 5-fluorouracilDrug
docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
radiotherapyRadiation
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
cetuximabDrug
400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment
cisplatinDrug
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
radiotherapyRadiation
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006) Receives: Drug: docetaxel - cisplatin - 5-fluorouracil; Radiation: radiotherapy; Drug: cetuximab |
| ARM B | Active comparator | RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003) Receives: Drug: cisplatin; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (4)
Incidence of acute and late toxicities in the two arms
Measured: 5 years
Progression free survival
Measured: 5 years
Locoregional control
Measured: 5 years
Response rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startSep 2009
- Primary completion31 Dec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCO MERLANO, Gruppo Oncologico del Nord-Ovest
- Investigators
- MARCO MERLANO, MD, Principal investigator, ASCO, ESMO, AIOM, G.O.N.O.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999700
- Sponsor's protocol ID
- EUDRACT NUMBER 2009-013402-14
- Acronym
- INTERCEPTOR
- Status last verified
- Sep 2017
- First submitted
- 16 Oct 2009
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
- J.P. Pignon et al. Lancet 2000
- A. Forastiere et al., New Engl J Med 2001
- Adelstein DJ J.Clin.Oncol. 2003
- Henke, New England 2004
- J.A. Bonner et al., New Engl J Med 2006
Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146.
PubMed 16476835- Posner M et al, New Engl J Med 2007
- Vermorken J et al, New Engl J Med 2007
- Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7.
PubMed 12927569
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
- ClinicalTrials.gov ID
- NCT00999700
- Acronym / sponsor ID
- INTERCEPTOR / EUDRACT NUMBER 2009-013402-14
- Keywords
- Locally advanced HNSCC, Chemo-radiation, Induction chemotherapy, Stage III/IV, Unresectable disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Oct 2009 (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.
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
Detailed description
The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: docetaxel - cisplatin - 5-fluorouracil, Radiation: radiotherapy, Drug: cetuximabInduction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006) |
| ARM B | Active comparator | Drug: cisplatin, Radiation: radiotherapyRT + Cddp (RTOG, Adelstein, J Clin Oncol 2003) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- > 18 years of age
- Histologically or cytologically confirmed diagnosis of HNSCC
- Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)
- At least one uni-dimensional measurable lesion either by CT scan or MRI
- Signed written informed consents prior to beginning protocol
Key exclusion criteria (16 listed)
- Prior systemic chemotherapy and/or radiotherapy
- Known peripheral neuropathy > grade 2 NCI-CTC version 3.0
- Known chronic heart failure
- Prior surgery, excluding prior diagnostic biopsy
- Known drug abuse
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 |
|---|---|---|
| docetaxel - cisplatin - 5-fluorouracildocetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21 | Drug | ARM A |
| radiotherapyConformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated. | Radiation | ARM A |
| cetuximab400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment | Drug | ARM A |
| cisplatinCisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment. | Drug | ARM B |
| radiotherapyConformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated. | Radiation | ARM B |
Primary outcome
Overall survival
Time frame: 5 years
4 secondary outcomes
Incidence of acute and late toxicities in the two arms
Time frame: 5 years
Progression free survival
Time frame: 5 years
Locoregional control
Time frame: 5 years
Response rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Results publication- J.P. Pignon et al. Lancet 2000
- Results publication- A. Forastiere et al., New Engl J Med 2001
- Results publication- Adelstein DJ J.Clin.Oncol. 2003
- Results publication- Henke, New England 2004
- Results publication- J.A. Bonner et al., New Engl J Med 2006
- Results publication: PubMed 16476835Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146.
- Results publication- Posner M et al, New Engl J Med 2007
- Results publication- Vermorken J et al, New Engl J Med 2007
- Results publication- Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
- Results publication: PubMed 12927569Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7.
- click on "trials" for more informationsLink provided by the sponsor.
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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.
MARCO MERLANO, MD principal investigator
ASCO, ESMO, AIOM, G.O.N.O.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel - cisplatin - 5-fluorouracil, radiotherapy and cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Gruppo Oncologico del Nord-Ovest at 21 sites in Italy.
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 13 inclusion and 16 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall survival (time frame: 5 years). 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 NCT00999700, which also lists 10 linked publications.
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 5 Sep 2017.