Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

Trial Title: Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

NCT ID: NCT06477692

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Paclitaxel
Cisplatin
Carboplatin
Cetuximab

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: radiation ENI versus INRT

Primary purpose: Treatment

Masking: Single (Participant)

Masking description: Patients are blinded to their treatment.

Intervention:

Intervention type: Drug
Intervention name: ENI using IMRT with or without chemotherapy
Description: This study is a phase II single-blinded randomized trial comparing standard ENI with involved nodal radiotherapy. INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
Arm group label: Involved and suspicious lymph node delineation and targeting
Arm group label: Standard radiotherapy with elective neck irradiation (ENI)

Other name: cisplatin, cetuximab, or carboplatin- paclitaxel)

Intervention type: Radiation
Intervention name: INRT
Description: INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
Arm group label: Involved and suspicious lymph node delineation and targeting

Intervention type: Radiation
Intervention name: ENI
Description: ENI using IMRT with or without chemotherapy
Arm group label: Standard radiotherapy with elective neck irradiation (ENI)

Summary: To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. 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. Diagnostic lymph node excision (< 2 nodes) is also allowable. - Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer. - Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded - Age ≥ 18 years. - ECOG Performance Status 0-2 - All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, 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). - Neck CT and/or neck MRI, and PET-CT - Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Distant metastasis. Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast. - Inability to undergo PET-CT. - Stage I and II glottic carcinoma. - Gross total excision of both the primary and nodal disease. - 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. - Prior invasive malignancy with an expected disease-free interval of less than 3 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, in the opinion of the investigator, would limit compliance with study requirements. - History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: UT Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Contact:
Last name: Sarah Neufeld, MS

Contact backup:
Last name: David Sher, MD

Start date: December 1, 2024

Completion date: July 1, 2028

Lead sponsor:
Agency: University of Texas Southwestern Medical Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Texas Southwestern Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06477692