Locally Advanced Larynx, Hypopharyngeal Squamous Cell CancersPhase 1/2NCT02055989
A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
A Phase 1/2 study testing Dose-escalated radiotherapy level 1 and Sequential dose-escalated radiotherapy level 2 in people with Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers and Locally Advanced Thyroid Cancers, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers, Locally Advanced Thyroid Cancers
- What is being tested?
- Dose-escalated radiotherapy level 1 and Sequential dose-escalated radiotherapy level 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2002to Dec 2011
- Phase
- Phase 1/2
- 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
- Adult, Older adult
Who may be able to join
- Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
- Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
- Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation.
- High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique).
- Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted.
- Stage T1-4, N1-3, M0 disease
- Zubrod Performance Status 0-2
Who cannot join
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
- Prophylactic use of amifostine or pilocarpine is not allowed
- Brachytherapy is not allowed as part of the treatment
Trial locations and contacts
1 site in 1 country.
About this study
This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased.
This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. These two groups of patients are being treated differently and will be analysed separately.
Read more
The primary objective of this Phase I sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens.
DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions
DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily fractions and elective nodal levels 54 Gy in 30 daily fractions
- Conditions
- Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers, Locally Advanced Thyroid Cancers
- Being tested
- Dose-escalated radiotherapy level 1, Sequential dose-escalated radiotherapy level 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-escalated radiotherapy level 1Radiation
Sequential dose-escalated radiotherapy level 2Radiation
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalated radiotherapy level 1 | Experimental | Not described Receives: Radiation: Dose-escalated radiotherapy level 1 |
| Sequential dose-escalated radiotherapy level 2 | Experimental | Not described Receives: Radiation: Sequential dose-escalated radiotherapy level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
Measured: 12 months after radiotherapy
Secondary outcomes (7)
Acute toxicity
Measured: Up to 3 months after radiotheapy
Late toxicity
Measured: Up to 60 months after radiotherapy
Local control
Measured: Up to 60 months after radiotherapy
Loco-regional control
Measured: Up to 60 months after radiotherapy
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Measured: Up to 60 months after radiotherapy
Disease free survival
Measured: Up to 60 months after radiotherapy
Overall Survival
Measured: Up to 60 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2002
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Larynx, Hypopharyngeal Squamous Cell CancersStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris M Nutting, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055989
- Sponsor's protocol ID
- CCR 1978
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
- ClinicalTrials.gov ID
- NCT02055989
- Acronym / sponsor ID
- CCR 1978
- Conditions
- Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers, Locally Advanced Thyroid Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2011 (actual)
- First posted
- 5 Feb 2014 (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.
This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased.
This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. These two groups of patients are being treated differently and will be analysed separately.
The primary objective of this Phase I sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens.
DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions
DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily fractions and elective nodal levels 54 Gy in 30 daily fractions
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-escalated radiotherapy level 1 | Experimental | Radiation: Dose-escalated radiotherapy level 1 |
| Sequential dose-escalated radiotherapy level 2 | Experimental | Radiation: Sequential dose-escalated radiotherapy level 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
- Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
- Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation.
- High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique).
- Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted.
Key exclusion criteria (5 listed)
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
- Prophylactic use of amifostine or pilocarpine is not allowed
- Brachytherapy is not allowed as part of the 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 |
|---|---|---|
| Dose-escalated radiotherapy level 1 | Radiation | Dose-escalated radiotherapy level 1 |
| Sequential dose-escalated radiotherapy level 2 | Radiation | Sequential dose-escalated radiotherapy level 2 |
Primary outcome
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
Time frame: 12 months after radiotherapy
7 secondary outcomes
Acute toxicity
Time frame: Up to 3 months after radiotheapy
Late toxicity
Time frame: Up to 60 months after radiotherapy
Local control
Time frame: Up to 60 months after radiotherapy
Loco-regional control
Time frame: Up to 60 months after radiotherapy
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Time frame: Up to 60 months after radiotherapy
Disease free survival
Time frame: Up to 60 months after radiotherapy
Overall Survival
Time frame: Up to 60 months after radiotherapy
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 5 Feb 2014.
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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.
Chris M Nutting, PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose-escalated radiotherapy level 1 and Sequential dose-escalated radiotherapy level 2 in people with Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers and Locally Advanced Thyroid Cancers, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 7 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: finished, as of the sponsor's last update on 5 Feb 2014. 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 United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment. (time frame: 12 months after radiotherapy). 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 5 Feb 2014.