Back to resultsNab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer (OPTIMA)
Primary Purpose
Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel albumin-stabilized nanoparticle formulation
carboplatin
radiation therapy
paclitaxel
fluorouracil
hydroxyurea
cisplatin
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Human Papilloma Virus Infection
Eligibility Criteria
Inclusion Criteria:
- Patients must have pathologically confirmed HPV-positive squamous cell carcinoma
HPV testing must follow the following criteria
- HPV testing using an E6/E7 based assay is preferred, and does not require any validation (e.g. HPV in situ hybridization [ISH] or HPV E6/E7 polymerase chain reaction [PCR])
- For oropharyngeal tumors p16 immunohistochemistry (IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan/Lingen et al 2012); it is recommended that p16 IHC positivity is validated at a later point (during or after treatment) using an E6/E7 based test at the University of Chicago and provided slides will be used
- For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based testing) is required for enrollment and treatment initiation
- Availability of >= 10 unstained 5 micron slides
- Patients with American Joint Committee on Cancer (AJCC) (7th edition, 2010) nodal stage N2 or N3 or a T4 primary tumor
- The primary and nodal involvement must be assessable on clinical exam (mucosal and lymph node exam)
- The primary and nodal involvement must have been defined bi- or uni-dimensional measurements measurable by RECIST
- No previous radiation or chemotherapy for a head and neck cancer
- No surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy of the tumor is acceptable)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
- Leukocytes >= 3000/mm^3
- Platelets >= 100,000/mm^3
- Absolute neutrophil count >= 1,500
- Hemoglobin > 9.0 gm/dL
- Albumin > 2.9 gm/dL
- Total bilirubin =< 1.5 mg/dl
- Creatinine clearance > 45 mL/min (or serum creatinine [SCr] =< 1.5 mg/dL), normal within 2 weeks prior to start of treatment
- The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)
- Alkaline phosphatase =< 2.5 X ULN
- Patients must sign a study-specific informed consent form prior to study entry; patients should have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Unequivocal demonstration of distant metastases (M1 disease)
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival; including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance
- Pregnant and nursing women are excluded; men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy; women with child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening
- Other coexisting malignancies or malignancies diagnosed within the previous 3 years no evidence of disease for at least 3 years; exceptions to this include non-melanoma skin cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate cancer; other cancers that per assessment of the PI are not prognosis limiting can be allowed after review by the PI
- Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor; residual tumor is required for enrollment on study
- Patients receiving other investigational agents
- Peripheral neuropathy >= grade 1
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A (radiation therapy alone)
Group B (combination chemotherapy, low-dose radiation therapy)
Group C (combination chemotherapy, high-dose radiation)
Arm Description
Patients undergo radiation therapy once daily for weeks.
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.* *NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1
If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.
Secondary Outcome Measures
Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1
Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only
Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Overall Survival
Overall survival rate
Cancer-specific Survival
Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - < 1.0; 4 = Neutrophils < 0.5 or sepsis.
Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.
Full Information
NCT ID
NCT02258659
First Posted
September 19, 2014
Last Updated
August 28, 2023
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02258659
Brief Title
Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
Acronym
OPTIMA
Official Title
An Exploratory Pilot Study of Nab-paclitaxel Based Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Patients With Stage III and IV HPV-Related Oropharyngeal Cancer - the OPTIMA HPV Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2014 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) and carboplatin followed by response-based local therapy in treating patients with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and radiation therapy based on response (response-based therapy) and giving patients who are responding well lower doses of treatment may help reduce the occurrence of side effects.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the 2-year progression-free survival (PFS).
SECONDARY OBJECTIVES:
I. Clinical complete response rate (nab-paclitaxel based induction, compared to European Prospective Investigation into Cancer and Nutrition [EPIC] induction [paclitaxel based]).
II. Response rate (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).
III. Proportion of patients with >= 50% shrinkage by Response Evaluation Criteria In Solid Tumors (RECIST) (nab-paclitaxel based induction, compared to EPIC induction, paclitaxel based).
IV. Toxicity (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).
V. To assess swallowing function and speech at 6 months (mos) and 12 mos post therapy.
VI. To determine the rates of late toxicity with chemoradiation following surgery as determined by xerostomia, dental decay, osteroradionecrosis, G-tube dependency, tracheostomy placement and dysphagia.
VII. 2-year overall survival (OS) in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms.
VIII. 2-year PFS in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms - early and late toxicities.
IX. Evaluate need for post radiotherapy/chemoradiotherapy (RT/CRT) surgery on low- and intermediate-risk arms based on response from induction chemotherapy.
X. Evaluate in a descriptive manner the role of transoral robotic surgery (TORS) resection/lymph node dissection (LND) when integrated into a de-escalation trial.
TERTIARY OBJECTIVES:
I. To evaluate pathologic/histologic appearance of tumor after induction chemotherapy and after CRT.
II. Translational research on blood and tissue samples. III. To profile tumors genetically and immunologically in order to assess in a descriptive manner genetic or immunological features characteristic of clinical behavior.
OUTLINE:
INDUCTION CHEMOTHERAPY: All patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are then assigned to 1 of 3 treatment groups based on response to induction chemotherapy.
GROUP A (LOW-DOSE ARM): Patients undergo radiation therapy once daily for 5 weeks.
GROUP B (INTERMEDIATE-DOSE ARM): Patients receive hydroxyurea orally (PO) twice daily (BID) on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.
GROUP C (STANDARD-DOSE ARM): Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.*
*NOTE: At the discretion of the principal investigator (PI), patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.
After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Oropharynx
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (radiation therapy alone)
Arm Type
Experimental
Arm Description
Patients undergo radiation therapy once daily for weeks.
Arm Title
Group B (combination chemotherapy, low-dose radiation therapy)
Arm Type
Experimental
Arm Description
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Group C (combination chemotherapy, high-dose radiation)
Arm Type
Experimental
Arm Description
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.*
*NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.
Intervention Type
Drug
Intervention Name(s)
paclitaxel albumin-stabilized nanoparticle formulation
Other Intervention Name(s)
ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-fluorouracil, 5-Fluracil, 5-FU
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
Other Intervention Name(s)
HU, HYD, Hydrea, Hydroxycarbamide, Hydurea
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1
Description
If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.
Time Frame
Time from enrollment until disease progression or death from any cause, assessed at 2 years
Secondary Outcome Measure Information:
Title
Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1
Description
Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Time Frame
Up to 8 weeks after completion of CRT
Title
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only
Description
Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Time Frame
Up to 5 years
Title
Overall Survival
Description
Overall survival rate
Time Frame
From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years
Title
Cancer-specific Survival
Description
Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.
Time Frame
Up to 5 years
Title
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement
Description
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - < 1.0; 4 = Neutrophils < 0.5 or sepsis.
Time Frame
Up to 5 years
Title
Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia
Description
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Histologic Appearance of Post-induction Tumor Tissue
Description
Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
Time Frame
Up to 3 months post-treatment
Title
Histologic Appearance of Post-CRT Tumor Tissue
Description
Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
Time Frame
Up to 3 months post-treatment
Title
Changes in Reactive T Cells
Description
Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.
Time Frame
Baseline to up to 2 months after radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have pathologically confirmed HPV-positive squamous cell carcinoma
HPV testing must follow the following criteria
HPV testing using an E6/E7 based assay is preferred, and does not require any validation (e.g. HPV in situ hybridization [ISH] or HPV E6/E7 polymerase chain reaction [PCR])
For oropharyngeal tumors p16 immunohistochemistry (IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan/Lingen et al 2012); it is recommended that p16 IHC positivity is validated at a later point (during or after treatment) using an E6/E7 based test at the University of Chicago and provided slides will be used
For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based testing) is required for enrollment and treatment initiation
Availability of >= 10 unstained 5 micron slides
Patients with American Joint Committee on Cancer (AJCC) (7th edition, 2010) nodal stage N2 or N3 or a T4 primary tumor
The primary and nodal involvement must be assessable on clinical exam (mucosal and lymph node exam)
The primary and nodal involvement must have been defined bi- or uni-dimensional measurements measurable by RECIST
No previous radiation or chemotherapy for a head and neck cancer
No surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy of the tumor is acceptable)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
Leukocytes >= 3000/mm^3
Platelets >= 100,000/mm^3
Absolute neutrophil count >= 1,500
Hemoglobin > 9.0 gm/dL
Albumin > 2.9 gm/dL
Total bilirubin =< 1.5 mg/dl
Creatinine clearance > 45 mL/min (or serum creatinine [SCr] =< 1.5 mg/dL), normal within 2 weeks prior to start of treatment
The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)
Alkaline phosphatase =< 2.5 X ULN
Patients must sign a study-specific informed consent form prior to study entry; patients should have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Unequivocal demonstration of distant metastases (M1 disease)
Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival; including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance
Pregnant and nursing women are excluded; men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy; women with child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening
Other coexisting malignancies or malignancies diagnosed within the previous 3 years no evidence of disease for at least 3 years; exceptions to this include non-melanoma skin cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate cancer; other cancers that per assessment of the PI are not prognosis limiting can be allowed after review by the PI
Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor; residual tumor is required for enrollment on study
Patients receiving other investigational agents
Peripheral neuropathy >= grade 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Vokes, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30481287
Citation
Seiwert TY, Foster CC, Blair EA, Karrison TG, Agrawal N, Melotek JM, Portugal L, Brisson RJ, Dekker A, Kochanny S, Gooi Z, Lingen MW, Villaflor VM, Ginat DT, Haraf DJ, Vokes EE. OPTIMA: a phase II dose and volume de-escalation trial for human papillomavirus-positive oropharyngeal cancer. Ann Oncol. 2019 Feb 1;30(2):297-302. doi: 10.1093/annonc/mdy522. Erratum In: Ann Oncol. 2019 Oct 1;30(10):1673.
Results Reference
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Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
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