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出境医 / 临床实验 / INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

Study Description
Brief Summary:
Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: Intensity modulated radiation therapy (IMRT) Phase 2

Detailed Description:
We recently completed and reported a successful study (INFIELD) using reduced elective dose (40 Gy) and volume (involved echelons + 1) for oropharynx and larynx cancer. In INRT-AIR (Involved Nodal Radiotherapy using AI-based Radiomics), we are eliminating the elective neck treatment altogether, using radiologic and radiomic-based criteria to focus treatment on the nodes themselves. Eligible patients include previously untreated patients with stage I-IVB oropharynx, larynx and hypopharynx cancer, excluding T1-2 glottic carcinoma. Patients requiring chemotherapy may receive cisplatin, cetuximab, or carboplatin-paclitexel.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INRT- AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy Using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: PET-CT at 3 months and ENT evaluation
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
 Radiation: Intensity modulated radiation therapy (IMRT)
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
Outcome Measures
Primary Outcome Measures :
  1. Crude risk of solitary elective volume recurrence (SEVR) following INRT, according to NCI's CTCAE v4.0 toxicity criteria. [ Time Frame: 2 years ]
    Comparison of SEVR risks by p16 status and anatomic site


Secondary Outcome Measures :
  1. Locoregional control, progression-free survival, and overall survival [ Time Frame: 2 years ]
  2. Grade 3-4 acute and late toxicity [ Time Frame: 2 years ]
    According to NCI's CTCAE v4.0 toxicity criteria

  3. Gastrostomy placement and subsequent removal rate [ Time Frame: 2 years ]
  4. EORTC QLQ-C30 Summary score [ Time Frame: 36 months ]
    The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales. Patients rate overall health and quality of life.

  5. EORTC QLQ-C30 Physical and role functioning subscales [ Time Frame: 36 months ]
    Patients rate overall health and quality of life.

  6. EORTC HN35 Dry mouth and sticky saliva subscales [ Time Frame: 36 months ]
    Patients report to which extent they experience symptoms or problems during one week.

  7. MDADI global, emotional, functional and physical subscales [ Time Frame: 36 months ]
    Questionnaire asks for views about swallowing ability.

  8. EQ-5D global score (0-100) [ Time Frame: 36 months ]
    Patients describe health for current day regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
  2. Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
  3. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
  4. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  5. Age ≥ 18 years.
  6. ECOG Performance Status 0-2

  7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  8. Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
  9. Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
  10. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. Distant metastasis.
  2. Inability to undergo PET-CT.
  3. Stage I and II glottic carcinoma.
  4. Gross total excision of both the primary and nodal disease.
  5. Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met .
  6. Prior invasive malignancy with an expected disease-free interval of less than 3 years.
  7. Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
  8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  9. Subjects may not be receiving any other investigational agents.
  10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
  12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  13. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
Contacts and Locations

Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: David J Sher, MD, MPH UT Southwestern Medical Center
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		Crude risk of solitary elective volume recurrence (SEVR) following INRT, according to NCI's CTCAE v4.0 toxicity criteria. [ Time Frame: 2 years ]
Comparison of SEVR risks by p16 status and anatomic site
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • Locoregional control, progression-free survival, and overall survival [ Time Frame: 2 years ]
  • Grade 3-4 acute and late toxicity [ Time Frame: 2 years ]
    According to NCI's CTCAE v4.0 toxicity criteria
  • Gastrostomy placement and subsequent removal rate [ Time Frame: 2 years ]
  • EORTC QLQ-C30 Summary score [ Time Frame: 36 months ]
    The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales. Patients rate overall health and quality of life.
  • EORTC QLQ-C30 Physical and role functioning subscales [ Time Frame: 36 months ]
    Patients rate overall health and quality of life.
  • EORTC HN35 Dry mouth and sticky saliva subscales [ Time Frame: 36 months ]
    Patients report to which extent they experience symptoms or problems during one week.
  • MDADI global, emotional, functional and physical subscales [ Time Frame: 36 months ]
    Questionnaire asks for views about swallowing ability.
  • EQ-5D global score (0-100) [ Time Frame: 36 months ]
    Patients describe health for current day regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • EORTC QLQ-C30 Summary score [ Time Frame: 36 months ]
    Patients rate overall health and quality of life.
  • EORTC QLQ-C30 Physical and role functioning subscales [ Time Frame: 36 months ]
    Patients rate overall health and quality of life.
  • EORTC HN35 Dry mouth and sticky saliva subscales [ Time Frame: 36 months ]
    Patients report to which extent they experience symptoms or problems during one week.
  • MDADI global, emotional, functional and physical subscales [ Time Frame: 36 months ]
    Questionnaire asks for views about swallowing ability.
  • EQ-5D global score (0-100) [ Time Frame: 36 months ]
    Patients describe health for current day regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
Official Title  ICMJE INRT- AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy Using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma
Brief Summary Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.
Detailed Description We recently completed and reported a successful study (INFIELD) using reduced elective dose (40 Gy) and volume (involved echelons + 1) for oropharynx and larynx cancer. In INRT-AIR (Involved Nodal Radiotherapy using AI-based Radiomics), we are eliminating the elective neck treatment altogether, using radiologic and radiomic-based criteria to focus treatment on the nodes themselves. Eligible patients include previously untreated patients with stage I-IVB oropharynx, larynx and hypopharynx cancer, excluding T1-2 glottic carcinoma. Patients requiring chemotherapy may receive cisplatin, cetuximab, or carboplatin-paclitexel.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE Radiation: Intensity modulated radiation therapy (IMRT)
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
Study Arms  ICMJE Experimental: PET-CT at 3 months and ENT evaluation
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intervention: Radiation: Intensity modulated radiation therapy (IMRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 15, 2019) 		67
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
  2. Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
  3. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
  4. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  5. Age ≥ 18 years.
  6. ECOG Performance Status 0-2

  7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  8. Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
  9. Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
  10. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. Distant metastasis.
  2. Inability to undergo PET-CT.
  3. Stage I and II glottic carcinoma.
  4. Gross total excision of both the primary and nodal disease.
  5. Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met .
  6. Prior invasive malignancy with an expected disease-free interval of less than 3 years.
  7. Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
  8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  9. Subjects may not be receiving any other investigational agents.
  10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
  12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  13. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953976
Other Study ID Numbers  ICMJE STU 2019-0711
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Sher, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David J Sher, MD, MPH UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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