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Phase 2 N=72 Treatment

Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer

Head and Neck Cancer · Carcinoma, Squamous Cell · Neoplasms, Oral · Neoplasms, Pharyngeal

Enrolled (actual)
72
Serious AEs
48.6%
Results posted
Mar 2022
Primary outcome: Primary: Number of Patients With Solitary Elective Volume Recurrence — 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Intensity Modulated Radiation Therapy (Radiation); chemotherapy (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Dec 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Solitary Elective Volume Recurrence
SECONDARY
Quality of Life (QOL) Patient Reported Outcomes (PRO)
71.4; 76.9; 79.2; 85.9; 90.3; 87.4
SECONDARY
Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
3
SECONDARY
Total Number of Participants With Gastrostomy Dependence
31
SECONDARY
Patient Utilities
SECONDARY
Overall Survival
89
SECONDARY
Progression-free Survival
79
SECONDARY
Probability of Locoregional or Distant Tumor Failure
14; 14

Summary

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03067610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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