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Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01566435
First received: March 27, 2012
Last updated: April 27, 2016
Last verified: April 2016
Results First Received: September 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Neoplasms
Interventions: Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: Cisplatin
Drug: Fluorouracil
Radiation: Intensity modulated radiation therapy
Drug: Cetuximab
Procedure: Quality-of-life assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 08/09/2012 and closed to participant enrollment on 11/07/2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)

  1. nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15
  2. Cisplatin 75 mg/m^2 on Day 1
  3. 5-FU 750 mg/m^2 on Days 1-3

If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.

Definitive Therapy

  1. Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43
  2. Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
  3. If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks

Participant Flow for 3 periods

Period 1:   ACF Induction Therapy
    Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  

Period 2:   ACF Definitive Chemoradiation-cisplatin
    Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy  
STARTED     28  
COMPLETED     27  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 3:   ACF Definitive Chemoradiation-cetuximab
    Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)

  1. nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
  2. Cisplatin 75 mg/m2 on Day 1
  3. 5-FU 750 mg/m2 on Days 1-3

If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.

Definitive Therapy

  1. Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
  2. Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
  3. If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks

Baseline Measures
    Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean (Full Range)
  58.8  
  (43 to 74)  
Gender  
[units: participants]
 
Female     5  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     30  
Smoking history  
[units: participants]
 
Yes     23  
No     7  
T Stage [1]
[units: participants]
 
T2     8  
T3     13  
T4     9  
Primary tumor site  
[units: participants]
 
Oropharynx     18  
Larynx     9  
Hypopharynx     3  
[1]

-T Stage (primary tumor)

  • T2 = Tumor > 2 cm but not more than 4 cm in greatest dimension
  • T3 = Tumor > 4 cm in greatest dimension
  • T4a = Lip - Tumor invades through cortical bone, inferior alveolar nerve, floor of mouth, or skin of face, Oral cavity - Tumor invades adjacent structures (eg, through cortical bone into deep extrinsic muscle of the tongue, maxillary sinus, or skin of face
  • T4b - Tumor invades masticator space, pterygoid plates, or skull base and/or encases internal carotid artery



  Outcome Measures
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1.  Primary:   Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site   [ Time Frame: 6 weeks (2 cycles of therapy) ]

2.  Secondary:   Percentage of Participants With Partial Response (PR) at Primary Tumor Site   [ Time Frame: 6 weeks (2 cycles of therapy) ]

3.  Secondary:   Number of Participants Per Anatomic Tumor Response by CT Scan   [ Time Frame: 6 weeks (2 cycles of therapy) ]

4.  Secondary:   Overall Survival Rate   [ Time Frame: 2 years ]

5.  Secondary:   Disease-free Survival (DFS) Rate   [ Time Frame: 2 years ]

6.  Secondary:   Metabolic Tumor Response by FDG-PET/CT   [ Time Frame: 6 weeks (2 cycles of therapy) ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

7.  Secondary:   Compare Adverse Events From This Regimen to the ACCF Regimen   [ Time Frame: From start of treatment through 30 days after end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   Yes

8.  Secondary:   Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue   [ Time Frame: 6 weeks (2 cycles of therapy) ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

9.  Secondary:   Quality of Life (QOL)   [ Time Frame: Through one year after completion of treatment ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

10.  Secondary:   CR or PR at Regional Nodes   [ Time Frame: 6 weeks (2 cycles of therapy) ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

11.  Secondary:   Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue   [ Time Frame: 6 weeks (2 cycles of therapy) ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

12.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   03/2024   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Douglas Adkins, M.D.
Organization: Washington University School of Medicine
phone: 314-747-7402
e-mail: dadkins@dom.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01566435     History of Changes
Other Study ID Numbers: 201202113
Study First Received: March 27, 2012
Results First Received: September 8, 2015
Last Updated: April 27, 2016
Health Authority: United States: Institutional Review Board