Head and Neck CancerPhase 2NCT00256308
Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
A Phase 2 study testing Oxaliplatin and Radiation in people with Head and Neck Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. 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?
- Oxaliplatin and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Oct 2011
- 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
- All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis subglottis). Nasopharynx primary will be excluded.
- The resected tumor must have one or more of the following high risk features: histologic extracapsular nodal extension involvement of ≥ 2 regional lymph nodes, mucosal margin of resection with invasive cancer (limited to microscopic detection only), tumor with perineural invasion, tumor with lymphovascular invasion, oral cavity and oropharynx carcinomas with positive lymph nodes metastasis at level IV or V.
- Radiation must begin within 28 to 56 days after surgical resection.
- All subjects must be 18 years of age or older.
- Subjects must have a Zubrod performance of 0-2.
Who cannot join
- Subjects must not have distant metastatic disease (M1).
- Subjects must NOT have prior therapy with oxaliplatin.
- Subjects with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no increase surgical toxicity. The good response rate observed warrants its use in further clinical trials.
The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial in esophageal cancer. In this particular trial, eligibility included therapeutically naïve esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of 5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There was no surgical mortality. Only 1 subject developed post-operative tracheoesphageal fistula. The results of these trials described above indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.
Read the detailed description
Adjuvant treatment of resected head and neck cancers The incidence of locoregional failures and distant metastasis is high after primary resection of squamous cell carcinoma of the head and neck (HNSCC), especially in patients with unfavorable prognostic factors such as residual disease, histological evidence of extracapsular spread, and/or multiple neck nodes. RT is indicated as an adjuvant therapy to surgery. In the past 2 decades, RT was mainly delivered post-operatively, and the therapeutic gain with this combination is now well documented. Despite an overall 2-year freedom of recurrance of approximately of 70-75%, survival rates are usually poor in the whole HNSCC patient population, and they usually do not exceed 30 to 35% at 5 years. The incidence of metastases in locally advanced but resectable head and neck cancer can reach 15 to 20%. The role of systemic chemotherapy has been tested in clinical trials to determine if the addition of chemotherapy can decrease locoregional and distant failure and improve survival.
Oxaliplatin and radiation in solid tumors Oxalipaltin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. Results of previous trials indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.
Oxaliplatin and radiation in head and neck cancer Oxaliplatin and radiation has been used in a randomized phase II study comparing standard radiation with or without weekly oxaliplatin in the treatment of locally advanced nasopharyngeal carcinoma. Radiation was administered at 70-74 Gy to the primary tumor site, 60-64 Gy to the involved areas of the neck and 50 Gy to the uninvolved area of the neck. Chemotherapy with oxaliplatin at 70 mg/m2 was given weekly for 6 courses with standard radiation in the investigational arm. Interim results concurrent radiation with weekly oxaliplatin resulted in a higher complete response in the primary tumor site and in the cervical lymph nodes. There was no difference in the incidences of dry mouth, stomatitis, skin reaction, peripheral neuropathy or hematological toxicities between the 2 treatment arms. Patients receiving the concurrent radiation and oxaliplatin treatment did experience more gastrointestinal toxicities mostly nausea and vomiting. The only grade 3 toxicities are thrombocytopenia (5.1%), nausea/vomiting (12.8%) and skin reaction (25.6%).
Microscopically involved margins, involvement of two or more nodes, extracapusular spread, presence of perineural involvement, and vascular embolisms are associated with an approximately 25% to 30% probability of developing locoregional failure. The addition of cisplatin to radiation reduces the locoregional failure and distant metastasis. We propose to investigate the toxicities of using weekly oxaliplatin with radiation in the treatment of high risk resected head and neck patients since oxaliplatin has a better side effects profile. The high risk factors will be the same criteria utilized in both RTOG 9501 and EORTC 22931. They include microscopically involved margins, involvement of two or more nodes, extracapusular spread, presence of perineural involvement, vascular embolisms, and oral cavity or oropharyngeal carcinoma with lymph nodes metastasis at level IV or V.
- Conditions
- Head and Neck Cancer
- Being tested
- Oxaliplatin, Radiation
- Keywords
- Head and Neck Cancer, oxaliplatin, resected squamous cell carcinoma, Eloxatin™
- 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.
OxaliplatinDrug
Also called Eloxatin
70mg/m2 IV over 120 min once a week during radiation
RadiationProcedure or surgery
200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin | Experimental | Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday. Receives: Drug: Oxaliplatin; Procedure: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Toxicities
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Measured: 2 years
Secondary outcomes (4)
Locoregional Control Rate
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Measured: 2 years
Disease-free Survival Rate
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Progression-free survival: from date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration
Progression: Appearance of any new lesion/site. The site of the new lesion will be recorded. Death due to disease without prior documentation of progression and without symptomatic deterioration Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation
Measured: 2 years
Overall Survival Rate
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
From date of registration to date of death due to any cause
Measured: 2 years
Sites of Relapse
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startFeb 2005
- Primary completionMay 2010
- Study completionOct 2011
Why it stopped: Halted prematurely 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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Sai-Hong Ignatius Ou, University of California, Irvine
- Investigators
- Sai-Hong Ignatius Ou, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256308
- Sponsor's protocol ID
- UCI 04-40
- Other IDs
- 2004-3999
- Status last verified
- Apr 2018
- First submitted
- 17 Nov 2005
- Last updated
- 1 May 2018
- 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 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region
- ClinicalTrials.gov ID
- NCT00256308
- Acronym / sponsor ID
- UCI 04-40
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, oxaliplatin, resected squamous cell carcinoma, Eloxatin™
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely due to slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2005
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no increase surgical toxicity. The good response rate observed warrants its use in further clinical trials.
The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial in esophageal cancer. In this particular trial, eligibility included therapeutically naïve esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of 5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There was no surgical mortality. Only 1 subject developed post-operative tracheoesphageal fistula. The results of these trials described above indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.
Detailed description
Adjuvant treatment of resected head and neck cancers The incidence of locoregional failures and distant metastasis is high after primary resection of squamous cell carcinoma of the head and neck (HNSCC), especially in patients with unfavorable prognostic factors such as residual disease, histological evidence of extracapsular spread, and/or multiple neck nodes. RT is indicated as an adjuvant therapy to surgery. In the past 2 decades, RT was mainly delivered post-operatively, and the therapeutic gain with this combination is now well documented. Despite an overall 2-year freedom of recurrance of approximately of 70-75%, survival rates are usually poor in the whole HNSCC patient population, and they usually do not exceed 30 to 35% at 5 years. The incidence of metastases in locally advanced but resectable head and neck cancer can reach 15 to 20%. The role of systemic chemotherapy has been tested in clinical trials to determine if the addition of chemotherapy can decrease locoregional and distant failure and improve survival.
Oxaliplatin and radiation in solid tumors Oxalipaltin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. Results of previous trials indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.
Oxaliplatin and radiation in head and neck cancer Oxaliplatin and radiation has been used in a randomized phase II study comparing standard radiation with or without weekly oxaliplatin in the treatment of locally advanced nasopharyngeal carcinoma. Radiation was administered at 70-74 Gy to the primary tumor site, 60-64 Gy to the involved areas of the neck and 50 Gy to the uninvolved area of the neck. Chemotherapy with oxaliplatin at 70 mg/m2 was given weekly for 6 courses with standard radiation in the investigational arm. Interim results concurrent radiation with weekly oxaliplatin resulted in a higher complete response in the primary tumor site and in the cervical lymph nodes. There was no difference in the incidences of dry mouth, stomatitis, skin reaction, peripheral neuropathy or hematological toxicities between the 2 treatment arms. Patients receiving the concurrent radiation and oxaliplatin treatment did experience more gastrointestinal toxicities mostly nausea and vomiting. The only grade 3 toxicities are thrombocytopenia (5.1%), nausea/vomiting (12.8%) and skin reaction (25.6%).
Microscopically involved margins, involvement of two or more nodes, extracapusular spread, presence of perineural involvement, and vascular embolisms are associated with an approximately 25% to 30% probability of developing locoregional failure. The addition of cisplatin to radiation reduces the locoregional failure and distant metastasis. We propose to investigate the toxicities of using weekly oxaliplatin with radiation in the treatment of high risk resected head and neck patients since oxaliplatin has a better side effects profile. The high risk factors will be the same criteria utilized in both RTOG 9501 and EORTC 22931. They include microscopically involved margins, involvement of two or more nodes, extracapusular spread, presence of perineural involvement, vascular embolisms, and oral cavity or oropharyngeal carcinoma with lymph nodes metastasis at level IV or V.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin | Experimental | Drug: Oxaliplatin, Procedure: RadiationOxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis subglottis). Nasopharynx primary will be excluded.
- The resected tumor must have one or more of the following high risk features: histologic extracapsular nodal extension involvement of ≥ 2 regional lymph nodes, mucosal margin of resection with invasive cancer (limited to microscopic detection only), tumor with perineural invasion, tumor with lymphovascular invasion, oral cavity and oropharynx carcinomas with positive lymph nodes metastasis at level IV or V.
- Radiation must begin within 28 to 56 days after surgical resection.
- All subjects must be 18 years of age or older.
- Subjects must have a Zubrod performance of 0-2.
Key exclusion criteria (5 listed)
- Subjects must not have distant metastatic disease (M1).
- Subjects must NOT have prior therapy with oxaliplatin.
- Subjects with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
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 |
|---|---|---|
| OxaliplatinAlso: Eloxatin70mg/m2 IV over 120 min once a week during radiation | Drug | Oxaliplatin |
| Radiation200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday | Procedure or surgery | Oxaliplatin |
Primary outcome
Frequency and Severity of Toxicities
Time frame: 2 years
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
4 secondary outcomes
Locoregional Control Rate
Time frame: 2 years
Disease-free Survival Rate
Time frame: 2 years
Overall Survival Rate
Time frame: 2 years
Sites of Relapse
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- 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.
Sai-Hong Ignatius Ou, MD, PhD principal investigator
Chao Family Comprehensive Cancer Center
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 Oxaliplatin and Radiation in people with Head and Neck Cancer, run by University of California, Irvine 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 5 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: stopped early, as of the sponsor's last update on 1 May 2018. 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 1 May 2018). 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?
Frequency and Severity of Toxicities (time frame: 2 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 1 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.