Squamous Cell Carcinoma of the Head and NeckNCT02352792
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
A study testing radiochemotherapy with 70 Gy and radiochemotherapy with 77 Gy in people with Squamous Cell Carcinoma of the Head and Neck, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. 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?
- radiochemotherapy with 70 Gy and radiochemotherapy with 77 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Dec 2022
- Phase
- Interventional
- 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 verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
- measurabel disease by CT and/or MRT and/or FDG-PET-CT
- fit for chemotherapy
- no prior radiotherapy or major surgery in the head/neck region
- Karnofsky Index > 60%
- informed consent
Who cannot join
- uncontrolled secondary cancer
- distant metastases
- pregnancy
- expected malcompliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Tuebingen university, radiation oncology
Tübingen, Baden-Wurttemberg, 72076
Stefan Welz, Dr. med., +49 7071 29 86144, stefan.welz@med.uni-tuebigen.de
About this study
Official title: Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).
- Being tested
- radiochemotherapy with 70 Gy, radiochemotherapy with 77 Gy
- Keywords
- Local control
- 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.
radiochemotherapy with 70 GyRadiation
radiochemotherapy with 77 GyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks) Receives: Radiation: radiochemotherapy with 70 Gy |
| dose escalation | Experimental | Standard plus 10% dose escalation to the hypoxic volume Receives: Radiation: radiochemotherapy with 77 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to local recurrence
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 posted2 Feb 2015 (estimated)
- Study startDec 2008
- Primary completionDec 2017 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Welz, Dr. med., Principal investigator, radiation oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352792
- Sponsor's protocol ID
- 2.0
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
- ClinicalTrials.gov ID
- NCT02352792
- Acronym / sponsor ID
- 2.0
- Keywords
- Local control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Feb 2015 (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.
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Radiation: radiochemotherapy with 70 GyStandard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks) |
| dose escalation | Experimental | Radiation: radiochemotherapy with 77 GyStandard plus 10% dose escalation to the hypoxic volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
- measurabel disease by CT and/or MRT and/or FDG-PET-CT
- fit for chemotherapy
- no prior radiotherapy or major surgery in the head/neck region
- Karnofsky Index > 60%
Key exclusion criteria (4 listed)
- uncontrolled secondary cancer
- distant metastases
- pregnancy
- expected malcompliance
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 |
|---|---|---|
| radiochemotherapy with 70 Gy | Radiation | Standard therapy |
| radiochemotherapy with 77 Gy | Radiation | dose escalation |
Primary outcome
time to local recurrence
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 2 Feb 2015.
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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.
Stefan Welz, Dr. med. principal investigator
radiation oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiochemotherapy with 70 Gy and radiochemotherapy with 77 Gy in people with Squamous Cell Carcinoma of the Head and Neck, run by University Hospital Tuebingen at 1 site in Germany.
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 6 inclusion and 4 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 2 Feb 2015. 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 Germany. 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.
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?
Contact Daniel Zips, Prof. Dr. med. (+49 7071 29 82141, daniel.zips@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to local recurrence (time frame: 5 years). 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 2 Feb 2015.