Head and Neck NeoplasmsPhase 4NCT02015650
Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
A Phase 4 study testing Cetuximab and Mitomycin-C/ 5-Fluorouracil in people with Head and Neck Neoplasms, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis, increase in combination with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Cetuximab and Mitomycin-C/ 5-Fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2014to 19 Apr 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have a non-resectable cancer of head and neck
- must have a pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx or cancer of unknown primary site
- must have a stage III or IV disease with an expected survival time of ≥ 12 months with node status of N0-N2
- must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy
- must have a Karnofsky performance status (KPS) of ≥ 70 at the time of screening
- must be between ≥18 and ≤80 years of age
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- must have the following laboratory values:
- Analysis/International System of Units (SI units) Neutrophil count/≥ 1.5 G/l Platelet count/≥ 100 G/l Serum glutamate oxaloacetate transaminase (SGOT)/≤ 2 x the upper limit of normal Serum glutamate pyruvate transaminase (SGPT)/≤ 2 x the upper limit of normal Serum creatinine or estimated creatinine clearance/≤ 1.5mg/dl or Epidermal growth factor receptor (eGFR)≥ 50 ml/min/1.73m² Serum calcium/Within normal limits
- must be disease free from a previously treated malignancy for more than three years
- must provide a signed and dated written informed consent
- Female subject of childbearing potential must:
- Understand that the study medication could have an expected teratogenic risk
- Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 3 months after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception* Implant Levonorgestrel-releasing intrauterine system (IUS) Medroxyprogesterone acetate depot Tubal sterilisation Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.
- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 milli-International units (mIU)/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Agree to have a medically supervised pregnancy test every 4 weeks including 3 months after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- Male subject must:
- Agree to use condoms throughout study drug therapy, during any dose interruption and for up to 3 months after cessation of study therapy if his partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Who cannot join
- Evidence of distant metastatic disease
- Prior systemic chemotherapy within the last three years
- Previous surgery for the tumor under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx
- Prior radiation therapy to the head and neck
- Receiving radiation therapy as part of a postoperative regimen following primary surgical resection
- Pregnancy or breastfeeding
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- Patient received prior Cetuximab or murine monoclonal antibody therapy
- Patient received prior Mitomycin-C and 5-Fluorouracil
- Actual hemorrhages
- Stomatitis, ulcerations in the mouth and the gastrointestinal tract
- Actual severe diarrhea
- Severe infectious diseases (Hepatitis A, B, C, D HIV)
- Coagulation disorders
- Active vaccination
- Patient has a medical or psychological condition that would not permit the patient to complete the trial or sign the informed consent
- Active participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, Department for Radiooncology and Therapeutic Oncology
Innsbruck, Tyrol, 6020
About this study
Official title: Randomized Phase IV Trial to Compare Cetuximab With Concomitant Radiation Therapy With Concomitant Mitomycin-C and 5-Fluorouracil With Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis, increase in combination with radiotherapy. Mucositis, as a painful inflammation and ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third of the patients discontinued Chemotherapy because of the side effects. Accordingly to these side effects, patients eating habits get limited. This requires an increase of pain medication, mostly an opioid derivate, which causes side effects too, which requires other symptomatic medication. This requires a change of nutrition from hard to pappy food and at further impairing, liquid food is needed. A central vein catheter has to be done for parental nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of general condition and a dose reduction or treatment stop is needed. Accordingly, the results are treatment delay and prolongation of hospital stay.
Risk of the study will be the known side effects of the products: Mitomycin-C, 5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation thera-py. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Following benefits are expected.
Read more
Benefit for patient:
- Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste disturbances, dietary restrictions, dysphagia
- Decrease of pain medication and side effects caused by pain medication
- Decrease of surgical intervention (gastric tube, central venous catheter) and risks caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach, etc.)
- Improving of patients social functioning, social eating, social contact
- No interruptions of therapy
- Increase of life quality
- Weight stabilization
Benefit for clinical practice:
- Increase of compliance
- Fulfilling of complete therapy
- Hospital stays as planned
- Conditions
- Head and Neck Neoplasms
- Being tested
- Cetuximab, Mitomycin-C/ 5-Fluorouracil
- Keywords
- Locally advanced squamous cell carcinomas of head and neck
- 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.
CetuximabDrug
Patients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy.
Mitomycin-C/ 5-FluorouracilDrug
Patients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Active comparator | Patients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy. Receives: Drug: Cetuximab |
| Mitomycin-C / 5-Fluorouracil | Active comparator | Patients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8. Receives: Drug: Mitomycin-C/ 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
The primary endpoint of the study is to examine the quality of life, based on differences in acute and late side effects.
Measured: 3 years
Secondary outcomes (2)
Efficacy of Cetuximab plus radiation therapy
The secondary endpoint of the study is to determine the differences in response rates.
Measured: 3 years
Equality in therapy of Cetuximab plus radiation therapy versus Mitomycin C/5-Fluorouracil plus radiation therapy.
The secondary endpoint of the study is to examine differences in the rate of locoregional disease control, maintained for one year.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startApr 2014
- Primary completion19 Apr 2016
- Study completion19 Apr 2016
Why it stopped: Low Recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lukas, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015650
- Sponsor's protocol ID
- MITOCET
- Other IDs
- 2013-001296-20
- Status last verified
- May 2020
- First submitted
- 13 Dec 2013
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase IV Trial to Compare Cetuximab With Concomitant Radiation Therapy With Concomitant Mitomycin-C and 5-Fluorouracil With Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
- ClinicalTrials.gov ID
- NCT02015650
- Acronym / sponsor ID
- MITOCET
- Conditions
- Head and Neck Neoplasms
- Keywords
- Locally advanced squamous cell carcinomas of head and neck
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 19 Apr 2016 (actual)
- Study completion
- 19 Apr 2016 (actual)
- First posted
- 19 Dec 2013 (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 radio-chemotherapy has become a standard therapy for advanced squamous cell carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis, increase in combination with radiotherapy. Mucositis, as a painful inflammation and ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third of the patients discontinued Chemotherapy because of the side effects. Accordingly to these side effects, patients eating habits get limited. This requires an increase of pain medication, mostly an opioid derivate, which causes side effects too, which requires other symptomatic medication. This requires a change of nutrition from hard to pappy food and at further impairing, liquid food is needed. A central vein catheter has to be done for parental nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of general condition and a dose reduction or treatment stop is needed. Accordingly, the results are treatment delay and prolongation of hospital stay.
Risk of the study will be the known side effects of the products: Mitomycin-C, 5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation thera-py. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Following benefits are expected.
Benefit for patient:
- Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste disturbances, dietary restrictions, dysphagia
- Decrease of pain medication and side effects caused by pain medication
- Decrease of surgical intervention (gastric tube, central venous catheter) and risks caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach, etc.)
- Improving of patients social functioning, social eating, social contact
- No interruptions of therapy
- Increase of life quality
- Weight stabilization
Benefit for clinical practice:
- Increase of compliance
- Fulfilling of complete therapy
- Hospital stays as planned
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Active comparator | Drug: CetuximabPatients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy. |
| Mitomycin-C / 5-Fluorouracil | Active comparator | Drug: Mitomycin-C/ 5-FluorouracilPatients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- must have a non-resectable cancer of head and neck
- must have a pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx or cancer of unknown primary site
- must have a stage III or IV disease with an expected survival time of ≥ 12 months with node status of N0-N2
- must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy
- must have a Karnofsky performance status (KPS) of ≥ 70 at the time of screening
Key exclusion criteria (16 listed)
- Evidence of distant metastatic disease
- Prior systemic chemotherapy within the last three years
- Previous surgery for the tumor under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx
- Prior radiation therapy to the head and neck
- Receiving radiation therapy as part of a postoperative regimen following primary surgical resection
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 |
|---|---|---|
| CetuximabPatients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy. | Drug | Cetuximab |
| Mitomycin-C/ 5-FluorouracilPatients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8. | Drug | Mitomycin-C / 5-Fluorouracil |
Primary outcome
Quality of Life
Time frame: 3 years
The primary endpoint of the study is to examine the quality of life, based on differences in acute and late side effects.
2 secondary outcomes
Efficacy of Cetuximab plus radiation therapy
Time frame: 3 years
Equality in therapy of Cetuximab plus radiation therapy versus Mitomycin C/5-Fluorouracil plus radiation therapy.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low Recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetuximab and Mitomycin-C/ 5-Fluorouracil in people with Head and Neck Neoplasms, run by Medical University Innsbruck at 1 site in Austria.
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 19 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 May 2020. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Low Recruitment rate). Results are not available in the source record.
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?
Quality of Life (time frame: 3 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 18 May 2020.