Head and Neck CancerPhase 2NCT02126969
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN
A Phase 2 study testing Low dose fractionated radiation - 80cGy with chemotherapy and Docetaxel and Carboplatin AUC 6 in people with Head and Neck Cancer and Larynx, run by Susanne Arnold at 1 site in United States.
Trial summary
The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Larynx
- What is being tested?
- Low dose fractionated radiation - 80cGy with chemotherapy and Docetaxel and Carboplatin AUC 6
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 15 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
- Measurable disease.
- ECOG performance status of 0, 1 or 2
- No prior chemotherapy for the current locally advanced SCCHN.
- Age ≥18 years.
- Life expectancy of greater than 3 months
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- Normal organ and marrow function measured within 14 days of registration as defined below:
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 100,000/mcL
- total bilirubin < institutional upper limit of normal
- AST(SGOT ≤ 2.5 × institutional upper limit of normal
- Alkaline phosphatase ≤ 2.5 × institutional upper limit of normal
- creatinine within normal institutional limits
- OR
- o Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior chemotherapy for SCCHN
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women
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- HIV-positive patients on combination antiretroviral therapy
- Other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years.
- Patients with nasopharynx or salivary gland primary site
- Patients with distant metastatic disease (M1c)
- Patients with grade II or greater peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer
The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.
- Conditions
- Head and Neck Cancer, Larynx
- Being tested
- Low dose fractionated radiation - 80cGy with chemotherapy, Docetaxel and Carboplatin AUC 6
- Keywords
- Cancer, Low dose radiation
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose fractionated radiation - 80cGy with chemotherapyRadiation
Chemotherapy + 80 cGy of RT
Docetaxel and Carboplatin AUC 6Drug
Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy plus Radiation Therapy | Experimental | Low dose fractionated radiation - 80cGy with chemotherapy Receives: Radiation: Low dose fractionated radiation - 80cGy with chemotherapy |
| Chemotherapy without Radiation | Active comparator | Chemotherapy only Receives: Drug: Docetaxel and Carboplatin AUC 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Site Complete Response Rate
Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.
Measured: Up to 50 days
Secondary outcomes (3)
Overall Response Rate
To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): > 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 50 days
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
Quality of Life (QOL) will be measured pre- and post-treatment using a single 5-question QOL well-being survey. The change in score will be presented independently for each subpart of the QOL survey.
- Physical; scores range from 7-35; higher scores indicate increased well-being
- Social/family; scores range from 7-35; higher scores indicate increased well-being
- Emotional; scores range from 6-30; higher scores indicate increased well-being
- Functional; scores range from 7-35; higher scores indicate increased well-being
- Additional Concerns; scores range from 10-50; lower scores indicate increased well-being
- FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being
- FACT-H\&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being
- Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being
Measured: Up to 50 days (pre- and post-treatment)
3-year Overall Survival
3-year overall survival
Measured: From date of randomization until date of death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2018
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- Susanne M Arnold, MD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126969
- Sponsor's protocol ID
- MCC-13-HN-24
- Status last verified
- Feb 2023
- First submitted
- 23 Apr 2014
- Last updated
- 13 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02126969
- Acronym / sponsor ID
- MCC-13-HN-24
- Conditions
- Head and Neck Cancer, Larynx
- Keywords
- Cancer, Low dose radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy plus Radiation Therapy | Experimental | Radiation: Low dose fractionated radiation - 80cGy with chemotherapyLow dose fractionated radiation - 80cGy with chemotherapy |
| Chemotherapy without Radiation | Active comparator | Drug: Docetaxel and Carboplatin AUC 6Chemotherapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
- Measurable disease.
- ECOG performance status of 0, 1 or 2
- No prior chemotherapy for the current locally advanced SCCHN.
- Age ≥18 years.
Key exclusion criteria (11 listed)
- Prior chemotherapy for SCCHN
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Low dose fractionated radiation - 80cGy with chemotherapyChemotherapy + 80 cGy of RT | Radiation | Chemotherapy plus Radiation Therapy |
| Docetaxel and Carboplatin AUC 6Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation | Drug | Chemotherapy without Radiation |
Primary outcome
Primary Site Complete Response Rate
Time frame: Up to 50 days
Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.
3 secondary outcomes
Overall Response Rate
Time frame: Up to 50 days
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
Time frame: Up to 50 days (pre- and post-treatment)
3-year Overall Survival
Time frame: From date of randomization until date of death from any cause, assessed up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Susanne M Arnold, MD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
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 Low dose fractionated radiation - 80cGy with chemotherapy and Docetaxel and Carboplatin AUC 6 in people with Head and Neck Cancer and Larynx, run by Susanne Arnold at 1 site in United States.
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 17 inclusion and 11 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 13 Mar 2023. 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 States. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Site Complete Response Rate (time frame: Up to 50 days). 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 13 Mar 2023.