- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03067610
Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer (INFIELD)
A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center - Dallas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx. Squamous cell carcinoma of unknown primary is not allowed.
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Patients may undergo a diagnostic tonsillectomy, and diagnostic lymph node excision (< 2 nodes) is also allowable.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
- ECOG Performance Status 0-2
- Adequate organ and marrow function as defined below:
- leukocytes ≥ 3,000/mcL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
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.
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).
- Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- Neck CT and/or neck MRI, and whole body PET-CT.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Distant metastasis or adenopathy below the clavicles.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous primaries outside of the oropharynx and larynx.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 1 years
- Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- Subjects may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
- 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 would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- History of immunosuppression or autoimmunity, including HIV, and organ or stem cell transplant, or an autoimmune condition previously treated with immunosuppressive therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Radiation Therapy
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
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The radiotherapy plan wil be delivered in 2 sequential courses.
The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective).
The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
Other Names:
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Solitary Elective Volume Recurrence
Time Frame: 2 years
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The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years.
Patients who die before 2 years without an SEVR will be included in the denominator.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
Time Frame: 12 months
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Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning. |
12 months
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Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
Time Frame: 2 years
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Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered.
This was measured according to NCI's CTCAE v4.0 toxicity criteria.
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2 years
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Total Number of Participants With Gastrostomy Dependence
Time Frame: 2 years
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The prevalence of gastrostomy use up to 2 years will be described.
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2 years
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Patient Utilities
Time Frame: 2 years
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The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described.
Changes in patient utility will be analyzed using generalized estimated equations (GEE).
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2 years
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Overall Survival
Time Frame: 2 years
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Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
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2 years
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Progression-free Survival
Time Frame: 2 year
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Progression-free survival will be calculated from the initiation of treatment.
Progression is confirmed by biopsy, which will be used as the date of progression.
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2 year
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Probability of Locoregional or Distant Tumor Failure
Time Frame: 2 years
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The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk.
Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: David Sher, MD, MPH, U Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Otorhinolaryngologic Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Squamous Cell
- Neoplasms
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Mouth Neoplasms
- Pharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Paclitaxel
- Cisplatin
- Cetuximab
Other Study ID Numbers
- STU 052016-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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