Head and Neck CancerPhase 2/3PANTAPNCT01598402
Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia
A Phase 2/3 study testing amoxicillin/clavulanic acid suspension in people with Head and Neck Cancer, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life. 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?
- amoxicillin/clavulanic acid suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesNetherlands
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 2/3
- 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
- Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- Written informed consent
- Expected adequacy of follow-up
Who cannot join
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days before start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
C. Smorenburg, Md, +31 72-5484444, c.h.smorenburg@mca.nl
M. Komen, +31 72-5484444, manon.komen@mca.nl
- Recruiting
Ziekenhuis Rijnstate
Arnhem, Gelderland, 6800 TA
J. Blaisse, Md, +31 26-3788888, jblaiss@alysis.nl
S. Brouwer, +31 26-3788888, sbrouwer@rijnstate.nl
- Recruiting
University Medical Centre Groningen
Groningen, 9700 RB
J. Gietema, Md, +31 50 361 61 61, j.a.gietema@med.umcg.nl
G. Sieling, +31 50 361 61 61, g.c.m.sieling@umcg.nl
- Not yet recruiting
Medisch centrum Leeuwarden
Leeuwarden, 8934 AD
E. Fiets, Md, +31 58-2866666, edward.fiets@znb.nl
T. Rienks, +31 58-2866666, tineke.rienks@znb.nl
- Not yet recruiting
Academical Hospital Maastricht (AZM)
Maastricht
ann.hoeben@mumc.nl
A. Hoeben, PhD
- Recruiting
University Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, 6525 GH
C. van Herpen, Md, +31 24 361 03 53, c.vanherpen@onco.umcn.nl
C. Driessen, drs, +31 24 361 11 11 ext. pager 3438, c.driessen@onco.umcn.nl
About this study
Official title: Efficacy and Cost Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Locally Advanced Head and Neck Cancer to Prevent Aspiration Pneumonia. A Randomized Phase II-III Study
Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life.
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
Read the detailed description
Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer (LAHNC). It will be administered to patients for unresectable disease or for organ preservation as primary treatment. Furthermore, it can be used as postoperative treatment in case high risk recurrent disease is present. This treatment induces a high rate of acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with an immense impact on Quality of life (QoL).
Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.
Aspiration is seen in all primary sites of head and neck cancer, sometimes it is seen more frequently in patients with cancer of the larynx and hypopharynx. No data of prophylactic administration of antibiotics are available in LAHNC patients. However, a Cochrane review was published to assess the effects of prophylactic antibiotic regimens for the prevention of respiratory tract infections(RTIs) and overall mortality in adults receiving intensive care.
- Conditions
- Head and Neck Cancer
- Being tested
- amoxicillin/clavulanic acid suspension
- Keywords
- LAHNC, Locally Advanced Head and Neck Cancer
- 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.
amoxicillin/clavulanic acid suspensionDrug
Also called The total duration of the use of amoxicillin /clavulanic acid suspension will be between 20 and 27 days.
625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT
| Study group | Role | What they receive |
|---|---|---|
| No prophylactic treatment | No intervention | When a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics). |
| prophylactic treatment | Experimental | Administration of prophylactic amoxicillin/clavulanic acid suspension, 625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT. If a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics) Receives: Drug: amoxicillin/clavulanic acid suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of definite pneumonia and/ or suspected pneumonia
Definite pneumonia:
Evidence of pneumonia on chest radiography or 3 or more of the following:
Sustained fever (temperature> 100 f [38°C]), Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen
Suspected pneumonia:
At least 2 of the 4 following features are present, without evidence of pneumonia on chest radiography:
Sustained fever (temperature> 100 f [38°C]) Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Secondary outcomes (8)
effects on Quality of Life
to investigate the effects on QoL after prophylactic treatment with antibiotics
Patients fill in the following questionnaires:
QLQ-C30, EORTC H\&N35, PSHHN, EQ-5D and the VAS, SF-36
Measured: Baseline, Day 28 last day of CRT, 3,5 months after CRT
Number and kind of positive blood cultures
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
number of admissions to hospital
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Number of days of admission
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on mortality
Mortality due to definite and/or suspected pneumonia
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
effects on mucositis: grade and duration
Mucositis grade according to CTCAE v.4.0 and duration
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
side effects of amoxicillin/clavulanic acid
side effects of amoxicillin/clavulanic acid
Measured: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on numbers and causative agents of infections at other sites
numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT)
Measured: during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (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 CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. van Herpen, MD, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598402
- Sponsor's protocol ID
- UMCNONCO201007
- Acronym
- PANTAP
- Status last verified
- Jul 2013
- First submitted
- 2 Feb 2012
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Locally Advanced Head and Neck Cancer to Prevent Aspiration Pneumonia. A Randomized Phase II-III Study
- ClinicalTrials.gov ID
- NCT01598402
- Acronym / sponsor ID
- PANTAP / UMCNONCO201007
- Conditions
- Head and Neck Cancer
- Keywords
- LAHNC, Locally Advanced Head and Neck Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 May 2012 (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 head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life.
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
Detailed description
Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer (LAHNC). It will be administered to patients for unresectable disease or for organ preservation as primary treatment. Furthermore, it can be used as postoperative treatment in case high risk recurrent disease is present. This treatment induces a high rate of acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with an immense impact on Quality of life (QoL).
Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.
Aspiration is seen in all primary sites of head and neck cancer, sometimes it is seen more frequently in patients with cancer of the larynx and hypopharynx. No data of prophylactic administration of antibiotics are available in LAHNC patients. However, a Cochrane review was published to assess the effects of prophylactic antibiotic regimens for the prevention of respiratory tract infections(RTIs) and overall mortality in adults receiving intensive care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No prophylactic treatment | No intervention | –When a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics). |
| prophylactic treatment | Experimental | Drug: amoxicillin/clavulanic acid suspensionAdministration of prophylactic amoxicillin/clavulanic acid suspension, 625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT. If a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- Written informed consent
- Expected adequacy of follow-up
Key exclusion criteria (5 listed)
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days before start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
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 |
|---|---|---|
| amoxicillin/clavulanic acid suspensionAlso: The total duration of the use of amoxicillin /clavulanic acid suspension will be between 20 and 27 days.625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT | Drug | prophylactic treatment |
Primary outcome
the number of definite pneumonia and/ or suspected pneumonia
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Definite pneumonia: Evidence of pneumonia on chest radiography or 3 or more of the following: Sustained fever (temperature> 100 f [38°C]), Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen Suspected pneumonia: At least 2 of the 4 following features are present, without evidence of pneumonia on chest radiography: Sustained fever (temperature> 100 f [38°C]) Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen
8 secondary outcomes
effects on Quality of Life
Time frame: Baseline, Day 28 last day of CRT, 3,5 months after CRT
Number and kind of positive blood cultures
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
number of admissions to hospital
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Number of days of admission
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on mortality
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
effects on mucositis: grade and duration
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
side effects of amoxicillin/clavulanic acid
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on numbers and causative agents of infections at other sites
Time frame: during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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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.
C. van Herpen, MD principal investigator
University Medical Centre Nijmegen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing amoxicillin/clavulanic acid suspension in people with Head and Neck Cancer, run by Radboud University Medical Center at 6 sites in Netherlands.
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 3 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 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact C. van Herpen, Md (+31 24 361 03 53, c.vanherpen@onco.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of definite pneumonia and/ or suspected pneumonia (time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT). 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 15 Jul 2013.