Head and Neck Squamous Cell CarcinomaNCT02778191
Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Squamous Cell Carcinoma, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- cisplatin, carboplatin and 5-FU
- How many people
- 413 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2016to Mar 2017
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced head and neck squamous cell carcinoma
Who may be able to join
- Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
- Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
- Age ≤ 70 years
- No previous treatment for head and neck cancer
- No distant metastases
Who cannot join
- Previous treatment for head and neck cancer
- Distant metastases
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VUmc
Amsterdam
University Medical Center Groningen
Groningen, 9713 GZ
About this study
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
Read the detailed description
This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- cisplatin, carboplatin, 5-FU
- Keywords
- Head and neck squamous cell carcinoma, cisplatin, carboplatin, 5-fluorouracil
- 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.
cisplatinDrug
100 mg/m2 day 1, 22 and 43
carboplatinDrug
carboplatin 300-350 mg/m2 day 1, 22 and 43
5-FUDrug
5-FU 600 mg/m2 days 1-4, 22-25 and 43-46
| Study group | Role | What they receive |
|---|---|---|
| Concomitant cisplatin | Patients treated with concomitant cisplatin Receives: Drug: cisplatin | |
| Carboplatin plus 5-FU | Patients treated with carboplatin plus 5-FU Receives: Drug: carboplatin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy completion rate
The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.
Measured: 1 year
Secondary outcomes (7)
Overall survival
Measured: 1 year
Progression free survival
Measured: 1 year
Distant metastases
Measured: 1 year
Grade 3-4 acute toxicity
retrospective data collection
Measured: 1 year
Late toxicity
retrospective data collection
Measured: 1 year
Quality of life
EORTC questionnaire QLQ C30
Measured: 1 year
Quality of life
EORTC questionnaire HN35
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- S. Oosting, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778191
- Sponsor's protocol ID
- 201501099
- Status last verified
- May 2024
- First submitted
- 15 Dec 2015
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02778191
- Acronym / sponsor ID
- 201501099
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck squamous cell carcinoma, cisplatin, carboplatin, 5-fluorouracil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 May 2016 (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.
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
Detailed description
This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant cisplatin | – | Drug: cisplatinPatients treated with concomitant cisplatin |
| Carboplatin plus 5-FU | – | Drug: carboplatin, Drug: 5-FUPatients treated with carboplatin plus 5-FU |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced head and neck squamous cell carcinoma
Key inclusion criteria (5 listed)
- Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
- Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
- Age ≤ 70 years
- No previous treatment for head and neck cancer
- No distant metastases
Key exclusion criteria (2 listed)
- Previous treatment for head and neck cancer
- Distant metastases
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 |
|---|---|---|
| cisplatin100 mg/m2 day 1, 22 and 43 | Drug | Concomitant cisplatin |
| carboplatincarboplatin 300-350 mg/m2 day 1, 22 and 43 | Drug | Carboplatin plus 5-FU |
| 5-FU5-FU 600 mg/m2 days 1-4, 22-25 and 43-46 | Drug | Carboplatin plus 5-FU |
Primary outcome
Chemotherapy completion rate
Time frame: 1 year
The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.
7 secondary outcomes
Overall survival
Time frame: 1 year
Progression free survival
Time frame: 1 year
Distant metastases
Time frame: 1 year
Grade 3-4 acute toxicity
Time frame: 1 year
Late toxicity
Time frame: 1 year
Quality of life
Time frame: 1 year
Quality of life
Time frame: 1 year
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 6 May 2024.
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
S. Oosting, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by University Medical Center Groningen at 2 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 5 inclusion and 2 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Chemotherapy completion rate (time frame: 1 year). 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 6 May 2024.