OPTIMA: Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer

Sponsor
University of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02258659
Collaborator
National Cancer Institute (NCI) (NIH)
62
1
3
98.3
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the 2-year progression-free survival (PFS).
SECONDARY OBJECTIVES:
  1. Clinical complete response rate (nab-paclitaxel based induction, compared to European Prospective Investigation into Cancer and Nutrition [EPIC] induction [paclitaxel based]).

  2. Response rate (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).

  3. Proportion of patients with >= 50% shrinkage by Response Evaluation Criteria In Solid Tumors (RECIST) (nab-paclitaxel based induction, compared to EPIC induction, paclitaxel based).

  4. Toxicity (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).

  5. To assess swallowing function and speech at 6 months (mos) and 12 mos post therapy.

  6. 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.

  7. 2-year overall survival (OS) in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms.

  8. 2-year PFS in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms - early and late toxicities.

  9. Evaluate need for post radiotherapy/chemoradiotherapy (RT/CRT) surgery on low- and intermediate-risk arms based on response from induction chemotherapy.

  10. 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:
  1. To evaluate pathologic/histologic appearance of tumor after induction chemotherapy and after CRT.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 22, 2014
Actual Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (radiation therapy alone)

Patients undergo radiation therapy once daily for weeks.

Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
  • Drug: carboplatin
    Given IV
    Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
  • Radiation: radiation therapy
    Undergo radiation therapy
    Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
  • Other: laboratory biomarker analysis
    Correlative studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Experimental: Group B (combination chemotherapy, low-dose radiation therapy)

    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.

    Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Given IV
    Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
  • Drug: carboplatin
    Given IV
    Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
  • Radiation: radiation therapy
    Undergo radiation therapy
    Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
  • Drug: paclitaxel
    Given IV
    Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
  • Drug: fluorouracil
    Given IV
    Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
  • Drug: hydroxyurea
    Given PO
    Other Names:
  • HU
  • HYD
  • Hydrea
  • Hydroxycarbamide
  • Hydurea
  • Other: laboratory biomarker analysis
    Correlative studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Experimental: Group C (combination chemotherapy, high-dose radiation)

    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.

    Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Given IV
    Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
  • Drug: carboplatin
    Given IV
    Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
  • Radiation: radiation therapy
    Undergo radiation therapy
    Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
  • Drug: paclitaxel
    Given IV
    Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
  • Drug: fluorouracil
    Given IV
    Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
  • Drug: hydroxyurea
    Given PO
    Other Names:
  • HU
  • HYD
  • Hydrea
  • Hydroxycarbamide
  • Hydurea
  • Drug: cisplatin
    Given IV
    Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
  • Other: laboratory biomarker analysis
    Correlative studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1 [Time from enrollment until disease progression or death from any cause, assessed at 2 years]

      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

    1. Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1 [Up to 8 weeks after completion of CRT]

      Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.

    2. Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only [Up to 5 years]

      Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.

    3. Overall Survival [From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years]

      Overall survival rate

    4. Cancer-specific Survival [Up to 5 years]

      Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.

    5. Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement [Up to 5 years]

      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.

    6. Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia [Up to 5 years]

      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.

    Other Outcome Measures

    1. Histologic Appearance of Post-induction Tumor Tissue [Up to 3 months post-treatment]

      Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.

    2. Histologic Appearance of Post-CRT Tumor Tissue [Up to 3 months post-treatment]

      Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.

    3. Changes in Reactive T Cells [Baseline to up to 2 months after radiation therapy]

      Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Everett Vokes, MD, University of Chicago

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT02258659
    Other Study ID Numbers:
    • IRB14-0639
    • NCI-2014-01867
    • IRB14-0639
    • P30CA014599
    First Posted:
    Oct 7, 2014
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Period Title: Overall Study
    STARTED 62
    COMPLETED 61
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Overall Participants 62
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    60
    Sex: Female, Male (Count of Participants)
    Female
    3
    4.8%
    Male
    59
    95.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    2
    3.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    4
    6.5%
    White
    56
    90.3%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 62
    Number (90% Confidence Interval) [percentage of participants]
    94.5
    152.4%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Ten missing values
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 52
    Number (95% Confidence Interval) [percentage of participants]
    90
    145.2%
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    one missing value
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 61
    complete response
    13
    21%
    Partial Response
    80
    129%
    Stable Disease
    13
    21%
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 62
    Number (95% Confidence Interval) [percentage of participants]
    87
    140.3%
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 62
    Number (95% Confidence Interval) [percentage of participants]
    95
    153.2%
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 62
    Grade 3+ mucositis
    35
    56.5%
    Grade 3+ dermatitis
    12
    19.4%
    grade 3+ neutropenia
    29
    46.8%
    grade 3+ Anorexia
    5
    8.1%
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 62
    G-tube dependence
    18
    29%
    Dysphagia
    18
    29%
    8. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    zero analyzed because no data was collected
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 0
    9. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    zero analyzed because no data was collected
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 0
    10. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    zero analyzed because no data was collected
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    Measure Participants 0

    Adverse Events

    Time Frame up to 5 years
    Adverse Event Reporting Description
    Arm/Group Title Single Arm
    Arm/Group Description Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
    All Cause Mortality
    Single Arm
    Affected / at Risk (%) # Events
    Total 5/62 (8.1%)
    Serious Adverse Events
    Single Arm
    Affected / at Risk (%) # Events
    Total 5/62 (8.1%)
    Gastrointestinal disorders
    Abdominal pain 1/62 (1.6%)
    Constipation 1/62 (1.6%)
    Diarrhea 1/62 (1.6%)
    General disorders
    Edema limbs 1/62 (1.6%)
    Fatigue 1/62 (1.6%)
    Fever 2/62 (3.2%)
    Investigations
    Neutrophil count decreased 1/62 (1.6%)
    Metabolism and nutrition disorders
    Anorexia 1/62 (1.6%)
    Respiratory, thoracic and mediastinal disorders
    Aspiration 1/62 (1.6%)
    Productive cough 1/62 (1.6%)
    Other (Not Including Serious) Adverse Events
    Single Arm
    Affected / at Risk (%) # Events
    Total 60/62 (96.8%)
    Blood and lymphatic system disorders
    Anemia 24/62 (38.7%)
    Cardiac disorders
    Atrial fibrillation 4/62 (6.5%)
    Ear and labyrinth disorders
    Ear pain 4/62 (6.5%)
    Eye disorders
    Blurred vision 4/62 (6.5%)
    Eye disorders - Other, specify 4/62 (6.5%)
    Gastrointestinal disorders
    Abdominal pain 11/62 (17.7%)
    Constipation 51/62 (82.3%)
    Diarrhea 30/62 (48.4%)
    Dry mouth 44/62 (71%)
    Dysphagia 18/62 (29%)
    Esophageal pain 10/62 (16.1%)
    Gastroesophageal reflux disease 6/62 (9.7%)
    Mucositis oral 56/62 (90.3%)
    Nausea 56/62 (90.3%)
    Oral pain 21/62 (33.9%)
    Vomiting 24/62 (38.7%)
    General disorders
    Edema limbs 11/62 (17.7%)
    Fatigue 60/62 (96.8%)
    Fever 19/62 (30.6%)
    Neck edema 4/62 (6.5%)
    Pain 19/62 (30.6%)
    Infections and infestations
    Mucosal infection 6/62 (9.7%)
    Injury, poisoning and procedural complications
    Dermatitis radiation 45/62 (72.6%)
    Injury, poisoning and procedural complication 4/62 (6.5%)
    Investigations
    Alanine aminotransferase increased 13/62 (21%)
    Aspartate aminotransferase increased 9/62 (14.5%)
    Neutrophil count decreased 36/62 (58.1%)
    Platelet count decreased 36/62 (58.1%)
    Weight loss 25/62 (40.3%)
    White blood cell decreased 14/62 (22.6%)
    Metabolism and nutrition disorders
    Anorexia 48/62 (77.4%)
    Hypokalemia 4/62 (6.5%)
    Musculoskeletal and connective tissue disorders
    Bone pain 8/62 (12.9%)
    Myalgia 8/62 (12.9%)
    Pain in extremity 5/62 (8.1%)
    Nervous system disorders
    Dizziness 5/62 (8.1%)
    Dysgeusia 52/62 (83.9%)
    Headache 9/62 (14.5%)
    Peripheral sensory neuropathy 31/62 (50%)
    Psychiatric disorders
    Anxiety 12/62 (19.4%)
    Insomnia 10/62 (16.1%)
    Renal and urinary disorders
    Acute kidney injury 4/62 (6.5%)
    Respiratory, thoracic and mediastinal disorders
    Cough 16/62 (25.8%)
    Epistaxis 15/62 (24.2%)
    Hoarseness 5/62 (8.1%)
    Nasal congestion 9/62 (14.5%)
    Pharyngolaryngeal pain 13/62 (21%)
    Postnasal drip 4/62 (6.5%)
    Sore throat 6/62 (9.7%)
    Skin and subcutaneous tissue disorders
    Alopecia 6/62 (9.7%)
    Palmar-plantar erythrodysesthesia syndrome 15/62 (24.2%)
    Pruritus 17/62 (27.4%)
    Skin and subcutaneous tissue disorder 5/62 (8.1%)
    Skin ulceration 7/62 (11.3%)
    Vascular disorders
    Lymphedema 9/62 (14.5%)
    Thromboembolic event 6/62 (9.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Everett Vokes
    Organization University of Chicago
    Phone 773-702-9306
    Email evokes@medicine.bsd.uchicago.edu
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT02258659
    Other Study ID Numbers:
    • IRB14-0639
    • NCI-2014-01867
    • IRB14-0639
    • P30CA014599
    First Posted:
    Oct 7, 2014
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022