Head and Neck NeoplasmsPhase 2NCT01301248
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
A Phase 2 study testing Chemoradiation plus Cetuximab and Chemoradiation in people with Head and Neck Neoplasms and AJCC Stage III/IV, run by Theagenio Cancer Hospital at 1 site in Greece.
Trial summary
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, AJCC Stage III/IV
- What is being tested?
- Chemoradiation plus Cetuximab and Chemoradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2008to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
- hypopharynx; age of 18 years or more
- adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
- kidneys (creatinine clearance ≥ 60ml/min
- heart (no arrythmias, no heart failure) and
- bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
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- ECOG performance status 0 or 1 and
- stage III or IVa to b with measurable lesions
- written informed consent
Who cannot join
- prior radiotherapy
- chemotherapy
- concurrent active malignancies
- pregnancy
- breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
Read the detailed description
Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.
- Conditions
- Head and Neck Neoplasms, AJCC Stage III/IV
- Being tested
- Chemoradiation plus Cetuximab, Chemoradiation
- Keywords
- locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV
- Medical subject headings
- Head and Neck Neoplasms, 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.
Chemoradiation plus CetuximabOther
Also called Platinol, Erbitux
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)
ChemoradiationOther
Also called Platinol
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy/Cisplatin(GroupA) | Active comparator | Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2) Receives: Other: Chemoradiation |
| Radiotherapy/Cisplatin/Cetuximab(GroupB) | Experimental | Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation) Receives: Other: Chemoradiation plus Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine safety and toxicity of combination
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
Measured: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Secondary outcomes (3)
Overall survival time
Time from first administration of trial treatment to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Measured: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Progression-free survival time
Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Patients without event are censored on the date of last tumor assessment.
Measured: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Response
Complete response (CR) is defined as the total disappearance of radiographic evidence of tumour. Partial response (PR) is defined as the ≥50% reduction in the product of the maximal bidimensional tumour diameters. Stable disease defined any change between +25% and -50% in tumour size, and progressive disease included any increase >25% from baseline or the appearance of any new lesion. We record tumour shrinkage and time to the development of disease progression according to the revised RECIST criteria, v.1.1.
Measured: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startMar 2008
- Primary completionApr 2011
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theagenio Cancer Hospital
- Sponsor type
- Other government
- Investigators
- Charalambos Andreadis, MD, Principal investigator, Theagenio Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301248
- Sponsor's protocol ID
- EEEK2008RCT2
- Status last verified
- Apr 2011
- First submitted
- 22 Feb 2011
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT01301248
- Acronym / sponsor ID
- EEEK2008RCT2
- Conditions
- Head and Neck Neoplasms, AJCC Stage III/IV
- Keywords
- locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Theagenio Cancer HospitalOther government
- Study start
- Mar 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 23 Feb 2011 (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.
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
Detailed description
Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy/Cisplatin(GroupA) | Active comparator | Other: ChemoradiationRadiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2) |
| Radiotherapy/Cisplatin/Cetuximab(GroupB) | Experimental | Other: Chemoradiation plus CetuximabRadiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
- hypopharynx; age of 18 years or more
- adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
- kidneys (creatinine clearance ≥ 60ml/min
- heart (no arrythmias, no heart failure) and
Key exclusion criteria (5 listed)
- prior radiotherapy
- chemotherapy
- concurrent active malignancies
- pregnancy
- breast-feeding
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 |
|---|---|---|
| Chemoradiation plus CetuximabAlso: Platinol, ErbituxRadiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation) | Other | Radiotherapy/Cisplatin/Cetuximab(GroupB) |
| ChemoradiationAlso: PlatinolRadiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2 | Other | Radiotherapy/Cisplatin(GroupA) |
Primary outcome
Determine safety and toxicity of combination
Time frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
3 secondary outcomes
Overall survival time
Time frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Progression-free survival time
Time frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Response
Time frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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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.
Charalambos Andreadis, MD principal investigator
Theagenio Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiation plus Cetuximab and Chemoradiation in people with Head and Neck Neoplasms and AJCC Stage III/IV, run by Theagenio Cancer Hospital at 1 site in Greece.
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 9 inclusion and 5 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
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?
Determine safety and toxicity of combination (time frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months). 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 17 May 2011.