Head and Neck CancerPhase 2NCT00868491
Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer
A Phase 2 study testing docetaxel, cisplatin, 5-fluorouracil, radiotherapy and cetuximab, cisplatin in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- docetaxel, cisplatin, 5-fluorouracil, radiotherapy and cetuximab, cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2008to 30 Oct 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
- Squamous cell carcinoma, histologically proven
- Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage)
- Male or female ≥18 years of age
- Expected survival >6 months
- Presence of at least one bidimensionally measurable index lesion
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- Effective contraception for both male and female subjects if risk of conception exists
- WHO performance status 0-2
- Laboratory parameters:
- hemoglobin ≥100 g/L leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L platelet count > 100x109/L total bilirubin < 1.25x upper normal limit transaminases (ALT, AST) < 5x upper normal limit creatinine clearance ≥ 55 mls/minute
- Signed written informed consent
Who cannot join
- Metastatic disease
- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses
- ChT or XRT ineligibility:
- Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;
- Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
- Previous administration of EGFR pathway-targeting therapy
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- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol
- Participation in another clinical trial within 30 days prior to study entry
- Pregnancy or breast feeding
- History of severe acute pulmonary disease
- Any investigational agent within past 30 days
- Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix
- Known drug abuse / severe alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
- Active, uncontrolled infection
- Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.
Read the detailed description
The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor.
In this proposed single-institution non-randomized, one-arm, open label phase II study, the authors will test the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.
Chemotherapy doses will be as follows: docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles followed by cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20, cisplatin 30 mg/m2 I.V. weeks 14-20. Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used.
The planned number of patients to be included is 30 and anticipated enrolment period is 12 months.
The primary objective of the study is to determine locoregional control at 2 years post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile) of the proposed regimen, to determine complete response rate after induction ChT as well as 14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2 years, overall survival at 2 years and late toxicity including thyroid function.
Given the preliminary nature of the study, no stopping rule is prospectively planned outside of observed toxicity, which will be assessed and graded according to Common Terminology Criteria for Adverse Events version 3.0.
- Conditions
- Head and Neck Cancer
- Being tested
- docetaxel, cisplatin, 5-fluorouracil, radiotherapy, cetuximab, cisplatin
- Keywords
- head and neck cancer, inoperable, induction chemotherapy, concomitant radiochemotherapy, biological agent, efficacy, toxicity
- Medical subject headings
- Head and Neck Neoplasms
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/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles
radiotherapyRadiation
Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol
cetuximab, cisplatinDrug
Also called Erbitux
- cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20
- cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)
| Study group | Role | What they receive |
|---|---|---|
| induction chemotherapy plus chemo-immuno-radiotherapy | Experimental | TPF induction chemotheraopy, radiotehrapy, concomitant cisplatin and cetuximab Receives: Drug: docetaxel, cisplatin, 5-fluorouracil; Radiation: radiotherapy; Drug: cetuximab, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional control
Measured: at 2 years post-therapy
Secondary outcomes (5)
feasibility (toxicity profile) of the proposed regimen
Measured: during therapy
complete response rate
Measured: after induction ChT and 14-16 weeks after the therapy
disease free survival
Measured: at 2 years post-therapy
overall survival
Measured: at 2 years post-therapy
late toxicity including thyroid function
Measured: up to 2 years post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completion30 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Primož Strojan, MD, Principal investigator, Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868491
- Sponsor's protocol ID
- EMR-62202-717
- Status last verified
- Oct 2024
- First submitted
- 24 Mar 2009
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00868491
- Acronym / sponsor ID
- EMR-62202-717
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, inoperable, induction chemotherapy, concomitant radiochemotherapy, biological agent, efficacy, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- 30 Oct 2011 (actual)
- First posted
- 25 Mar 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.
The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.
Detailed description
The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor.
In this proposed single-institution non-randomized, one-arm, open label phase II study, the authors will test the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.
Chemotherapy doses will be as follows: docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles followed by cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20, cisplatin 30 mg/m2 I.V. weeks 14-20. Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used.
The planned number of patients to be included is 30 and anticipated enrolment period is 12 months.
The primary objective of the study is to determine locoregional control at 2 years post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile) of the proposed regimen, to determine complete response rate after induction ChT as well as 14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2 years, overall survival at 2 years and late toxicity including thyroid function.
Given the preliminary nature of the study, no stopping rule is prospectively planned outside of observed toxicity, which will be assessed and graded according to Common Terminology Criteria for Adverse Events version 3.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induction chemotherapy plus chemo-immuno-radiotherapy | Experimental | Drug: docetaxel, cisplatin, 5-fluorouracil, Radiation: radiotherapy, Drug: cetuximab, cisplatinTPF induction chemotheraopy, radiotehrapy, concomitant cisplatin and cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Squamous cell carcinoma, histologically proven
- Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage)
- Male or female ≥18 years of age
- Expected survival >6 months
Key exclusion criteria (17 listed)
- Metastatic disease
- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses
- ChT or XRT ineligibility:
- Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;
- Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
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/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles | Drug | induction chemotherapy plus chemo-immuno-radiotherapy |
| radiotherapyThree-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol | Radiation | induction chemotherapy plus chemo-immuno-radiotherapy |
| cetuximab, cisplatinAlso: Erbitux* cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20 * cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy) | Drug | induction chemotherapy plus chemo-immuno-radiotherapy |
Primary outcome
locoregional control
Time frame: at 2 years post-therapy
5 secondary outcomes
feasibility (toxicity profile) of the proposed regimen
Time frame: during therapy
complete response rate
Time frame: after induction ChT and 14-16 weeks after the therapy
disease free survival
Time frame: at 2 years post-therapy
overall survival
Time frame: at 2 years post-therapy
late toxicity including thyroid function
Time frame: up to 2 years post-therapy
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 18 Oct 2024.
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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.
Primož Strojan, MD principal investigator
Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia
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 docetaxel, cisplatin, 5-fluorouracil, radiotherapy and cetuximab, cisplatin in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 17 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 18 Oct 2024. 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 Slovenia. 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?
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?
locoregional control (time frame: at 2 years post-therapy). 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 18 Oct 2024.