Head and Neck CancerPhase 3NCT00360971
Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
A Phase 3 study testing palifermin, cisplatin and neck dissection in people with Head and Neck Cancer and Mucositis, run by Radiation Therapy Oncology Group at 48 sites in 2 countries.
Trial summary
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Mucositis, Pain
- What is being tested?
- palifermin, cisplatin and neck dissection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Jul 2006to Feb 2009
- Phase
- Phase 3
- 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
- Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;
- Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy;
- -2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy;
- Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry.
- Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup:
- 4.1 History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to registration;
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- 4.2 Chest x-ray (or Chest CT scan) within 6 weeks prior to registration;
- 4.3 MRI or CT scan with contrast of tumor site within 6 weeks prior to registration;
- 4.4 Assessment of mucositis and xerostomia within 2 weeks prior to registration;
- Zubrod Performance Status 0-1;
- Age > 18;
- Adequate bone marrow function, defined as follows:
- 7.1 Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
- 7.2 Platelets > 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
- 7.3 Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.)
- Adequate hepatic function with bilirubin < 1.5 mg/dl, AST or ALT < 2 x ULN within 2 weeks prior to registration;
- Adequate renal function with serum creatinine < 1.5 mg/dl and creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:
- CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
- Normal serum calcium or normal corrected serum calcium within 2 weeks prior to registration; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) + patient's measured calcium (mg/dl);
- Serum pregnancy test for women of childbearing potential within 2 weeks prior to registration;
- Women of childbearing potential and male participants must practice adequate contraception.
- Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
- Patient must sign study specific informed consent prior to study entry.
Who cannot join
- Patients with a history of prior head and neck squamous cancer are ineligible;
- Stage IVC (AJCC, 6th edition) [Any T, Any N, M1] or distant metastases at protocol study entry; T1N1M0 patients are excluded.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
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- Severe, active co-morbidity, defined as follows:
- 7.1 Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV (see Appendix II);
- 7.2 Transmural myocardial infarction within the last 6 months;
- 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- 7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
- 7.6 Patients known to be sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV);
- 7.7 Patients known to be sero-positive for human immunodeficiency virus (HIV) or patients with Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with HIV or AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- 7.8 A history of pancreatitis.
- Collagen vascular disease, such as scleroderma, as this disease is thought to predispose patients to increased risk for radiation-associated toxicities;
- Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin;
- Prior allergic reaction or known sensitivity to any of the agents administered during dosing, including E. coli-derived products, such as Nutropin®, Neupogen®, Humulin®, Roferon®; Neumega®, Neulasta®), IntronA®, Betaseron®;
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States47 sites
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, 46016
Auburn Radiation Oncology
Auburn, California, 95603
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, 08103
Radiation Oncology Centers - Cameron Park
Cameron Park, California, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, 95926
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, 27835-6028
Sharon Regional Cancer Care Center- Hermitage
Hermitage, Pennsylvania, 16148
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
Johnson City Medical Center Hospital
Johnson City, Tennessee, 37604
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143
Intercommunity Cancer Center
Monroeville, Pennsylvania, 15146
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, 15065
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Radiation Oncology Center - Roseville
Roseville, California, 95661
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815
Mercy General Hospital
Sacramento, California, 95819
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Somerset Oncology Center
Somerset, Pennsylvania, 15501
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Torrance Memorial Medical Center
Torrance, California, 90509
Solano Radiation Oncology Center
Vacaville, California, 95687
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, 08360
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, 26003
Cancer Treatment Center
Wooster, Ohio, 44691
Canada1 site
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2
About this study
Official title: A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Therapy With Concurrent Chemotherapy (Followed by Surgery for Selected Patients)
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer.
PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days [15 weeks] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and chemotherapy.
Secondary
- Compare incidence and time to onset of Grades 3 or 4 oral mucositis in patients treated with these regimens.
- Compare overall and progression-free survival and time to second primary in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (III vs IVA or IVB), tumor site (oral cavity or oropharynx vs hypopharynx or larynx), and radiotherapy technique used on study (intensity-modulated radiotherapy [IMRT] vs 3-dimensional conformal radiotherapy [3D-CRT]). Patients are randomized to 1 of 2 treatment arms.
Mucositis, pain, and symptom burden are assessed at baseline, during radiotherapy, and post radiotherapy. Xerostomia is assessed at baseline, during radiotherapy, and several times after completion of study therapy.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 298 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer, Mucositis, Pain, Radiation Toxicity
- Being tested
- palifermin, cisplatin, placebo, neck dissection, radiation therapy
- Keywords
- mucositis, pain, radiation toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Pain, Radiation Injuries, 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.
paliferminBiological
Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
cisplatinDrug
Patients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course.
placeboOther
Four doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
neck dissectionProcedure or surgery
A neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline.
radiation therapyRadiation
A radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Palifermin | Experimental | Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients. Receives: Biological: palifermin; Drug: cisplatin; Procedure: neck dissection; Radiation: radiation therapy |
| Placebo | Placebo comparator | Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients. Receives: Drug: cisplatin; Other: placebo; Procedure: neck dissection; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Oral Mucositis as Measured in Terms of Days
Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.
This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.
Statistical testing was not done due to the small sample size.
Measured: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Secondary outcomes (5)
Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Measured: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Measured: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Overall Survival
An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.
Measured: From randomization to maximum follow-up at time of analysis of 21 months
Progression-free Survival
An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.
Measured: From randomization to maximum follow-up at time of analysis of 21 months
Time to Second Primary Tumor
An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.
Measured: From randomization to maximum follow-up at time of analysis of 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2008
- Study completionFeb 2009
Why it stopped: Due to positive preliminary results from other palifermin studies.
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.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David I. Rosenthal, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360971
- Sponsor's protocol ID
- RTOG-0435
- Other IDs
- CDR0000491088
- Status last verified
- Nov 2017
- First submitted
- 3 Aug 2006
- Last updated
- 26 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Therapy With Concurrent Chemotherapy (Followed by Surgery for Selected Patients)
- ClinicalTrials.gov ID
- NCT00360971
- Acronym / sponsor ID
- RTOG-0435
- Conditions
- Head and Neck Cancer, Mucositis, Pain, Radiation Toxicity
- Keywords
- mucositis, pain, radiation toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to positive preliminary results from other palifermin studies.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer.
PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days [15 weeks] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and chemotherapy.
Secondary
- Compare incidence and time to onset of Grades 3 or 4 oral mucositis in patients treated with these regimens.
- Compare overall and progression-free survival and time to second primary in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (III vs IVA or IVB), tumor site (oral cavity or oropharynx vs hypopharynx or larynx), and radiotherapy technique used on study (intensity-modulated radiotherapy [IMRT] vs 3-dimensional conformal radiotherapy [3D-CRT]). Patients are randomized to 1 of 2 treatment arms.
Mucositis, pain, and symptom burden are assessed at baseline, during radiotherapy, and post radiotherapy. Xerostomia is assessed at baseline, during radiotherapy, and several times after completion of study therapy.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 298 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palifermin | Experimental | Biological: palifermin, Drug: cisplatin, Procedure: neck dissection, Radiation: radiation therapyConcurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients. |
| Placebo | Placebo comparator | Drug: cisplatin, Other: placebo, Procedure: neck dissection, Radiation: radiation therapyConcurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;
- Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy;
- -2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy;
- Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry.
- Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup:
Key exclusion criteria (19 listed)
- Patients with a history of prior head and neck squamous cancer are ineligible;
- Stage IVC (AJCC, 6th edition) [Any T, Any N, M1] or distant metastases at protocol study entry; T1N1M0 patients are excluded.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
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 |
|---|---|---|
| paliferminFour doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19. | Biological | Palifermin |
| cisplatinPatients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course. | Drug | Palifermin, Placebo |
| placeboFour doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19. | Other | Placebo |
| neck dissectionA neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline. | Procedure or surgery | Palifermin, Placebo |
| radiation therapyA radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment. | Radiation | Palifermin, Placebo |
Primary outcome
Duration of Oral Mucositis as Measured in Terms of Days
Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.
5 secondary outcomes
Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale
Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Overall Survival
Time frame: From randomization to maximum follow-up at time of analysis of 21 months
Progression-free Survival
Time frame: From randomization to maximum follow-up at time of analysis of 21 months
Time to Second Primary Tumor
Time frame: From randomization to maximum follow-up at time of analysis of 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David I. Rosenthal, MD study chair
M.D. Anderson Cancer Center
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing palifermin, cisplatin and neck dissection in people with Head and Neck Cancer and Mucositis, run by Radiation Therapy Oncology Group at 48 sites in 2 countries.
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 23 inclusion and 19 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 26 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 48 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2014). 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?
Duration of Oral Mucositis as Measured in Terms of Days (time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.). 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 26 Dec 2017.