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

NCT03067610 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STU 052016-044
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Solitary Elective Volume Recurrence

  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.

  2 years

Secondary Outcomes (7)

• Quality of Life (QOL) Patient Reported Outcomes (PRO)

  12 months

• Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)

  2 years

• Total Number of Participants With Gastrostomy Dependence

  2 years

• Patient Utilities

  2 years

• Overall Survival

  2 years

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

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

Radiation: Intensity Modulated Radiation Therapy; Drug: chemotherapy

Interventions

Intensity Modulated Radiation Therapy RADIATION

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.

Also known as: IMRT

Radiation Therapy

chemotherapy DRUG

chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion

Also known as: cisplatin, cetuximab, or carboplatin-paclitaxel

Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Mouth Neoplasms; Pharyngeal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy; Cisplatin; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Mouth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. David Sher
• Organization: University of Texas Southwestern Medical Center

david.sher@utsouthwestern.edu

214/645-7607

Study Officials

• David Sher, MD, MPH

  U Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: radiation therapy

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: March 1, 2017
• Study Start: January 20, 2017
• Primary Completion: December 21, 2020
• Study Completion: March 9, 2021
• Last Updated: March 17, 2022
• Results First Posted: March 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)