Squamous Cell Carcinoma of the Head and NeckPhase 2NCT01221753
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
A Phase 2 study testing docetaxel, cisplatin and 5-FU in people with Squamous Cell Carcinoma of the Head and Neck and Human Papilloma Virus, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck, Human Papilloma Virus
- What is being tested?
- docetaxel, cisplatin and 5-FU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2017
- 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 squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
- Stage 3 or 4 disease without evidence of distant metastases
- At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
- 18 years of age or older
- No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
- ECOG Performance Status of 0 or 1
Show all 9Show fewer
- No active alcohol addiction
- Adequate bone marrow, hepatic and renal function as defined in the protocol
- Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment
Who cannot join
- Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
- Previous or current malignancies at other sites
- Symptomatic peripheral neuropathy of grade 2 or greater
- Symptomatic altered hearing greater than grade 2
- Other serious illnesses or medical conditions
- Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
- Concurrent treatment with any other anticancer therapy
- Participation in an investigational trial within 30 days of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.
Read the detailed description
OBJECTIVES:
Primary
To determine rate of local-regional control at 2 years
Secondary
To determine Progression Free Survival at 2 and 5 years
To determine Overall Survival at 2 and 5 years
To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years
- Keywords
- SSCHN, HPV, IMRT
- 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.
docetaxelDrug
Also called Taxotere, Docefrez
cisplatinDrug
Also called Platinol-AQ
Given intravenously on day 1 of each cycle
5-FUDrug
Also called 5-fluorouracil
IMRTRadiation
Also called Intensity modulated radiation therapy
cetuximabDrug
Also called Erbitux
carboplatinDrug
Also called Paraplatin
| Study group | Role | What they receive |
|---|---|---|
| TPF Induction Chemotherapy followed by Chemoradiotherapy | Experimental | Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks. Receives: Drug: docetaxel; Drug: cisplatin; Drug: 5-FU; Radiation: IMRT; Drug: cetuximab; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Local-Regional Control Rate
2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.
Secondary outcomes (1)
4-y Overall Survival Rate
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.
Measured: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2017
Why it stopped: Due to slow accrual
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 Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert I. Haddad, MD, Dana-Farber Cancer Institute
- Investigators
- Robert Haddad, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221753
- Sponsor's protocol ID
- 10-038
- Status last verified
- Nov 2017
- First submitted
- 21 Sep 2010
- Last updated
- 6 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no data available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx
- ClinicalTrials.gov ID
- NCT01221753
- Acronym / sponsor ID
- 10-038
- Keywords
- SSCHN, HPV, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.
Detailed description
OBJECTIVES:
Primary
To determine rate of local-regional control at 2 years
Secondary
To determine Progression Free Survival at 2 and 5 years
To determine Overall Survival at 2 and 5 years
To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPF Induction Chemotherapy followed by Chemoradiotherapy | Experimental | Drug: docetaxel, Drug: cisplatin, Drug: 5-FU, Radiation: IMRT, Drug: cetuximab, Drug: carboplatinPatients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
- Stage 3 or 4 disease without evidence of distant metastases
- At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
- 18 years of age or older
- No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
Key exclusion criteria (8 listed)
- Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
- Previous or current malignancies at other sites
- Symptomatic peripheral neuropathy of grade 2 or greater
- Symptomatic altered hearing greater than grade 2
- Other serious illnesses or medical conditions
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 |
|---|---|---|
| docetaxelAlso: Taxotere, Docefrez | Drug | TPF Induction Chemotherapy followed by Chemoradiotherapy |
| cisplatinAlso: Platinol-AQGiven intravenously on day 1 of each cycle | Drug | TPF Induction Chemotherapy followed by Chemoradiotherapy |
| 5-FUAlso: 5-fluorouracil | Drug | TPF Induction Chemotherapy followed by Chemoradiotherapy |
| IMRTAlso: Intensity modulated radiation therapy | Radiation | TPF Induction Chemotherapy followed by Chemoradiotherapy |
| cetuximabAlso: Erbitux | Drug | TPF Induction Chemotherapy followed by Chemoradiotherapy |
| carboplatinAlso: Paraplatin | Drug | TPF Induction Chemotherapy followed by Chemoradiotherapy |
Primary outcome
2-Year Local-Regional Control Rate
Time frame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.
2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
1 secondary outcome
4-y Overall Survival Rate
Time frame: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no data available.
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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.
Robert Haddad, MD principal investigator
Dana-Farber Cancer Institute
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 docetaxel, cisplatin and 5-FU in people with Squamous Cell Carcinoma of the Head and Neck and Human Papilloma Virus, run by Dana-Farber Cancer Institute 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 9 inclusion and 8 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 6 Dec 2017. 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 6 Dec 2016). 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?
2-Year Local-Regional Control Rate (time frame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.). 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 Dec 2017.