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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953976
• Other study ID #: STU 2019-0711
• Status: Completed
• Phase: Phase 2
• Start date: July 23, 2019
• Est. completion date: January 22, 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 22, 2024
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the risk of solitary elective volume recurrence following elective volume reduction using INRT.	Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence	2 years
Secondary	Comparison of SEVR risks by p16 status and anatomic site		2 years
Secondary	EORTC QLQ-C30 Summary score	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.	36 months
Secondary	EORTC QLQ-C30 Physical and role functioning subscales	Patients rate overall health and quality of life.	36 months
Secondary	EORTC HN35 Dry mouth and sticky saliva subscales	Patients report to which extent they experience symptoms or problems during one week.	36 months
Secondary	MDADI global, emotional, functional and physical subscales	Questionnaire asks for views about swallowing ability.	36 months
Secondary	EQ-5D global score (0-100)	Patients describe health for current day regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	36 months
Secondary	Grade 3-4 acute and late toxicity	According to NCI's CTCAE v4.0 toxicity criteria	2 years
Secondary	Gastrostomy placement and subsequent removal rate	To estimate the rates gastrostomy dependence at 3, 6, 12 and 24 months following treatment with INRT.	2 years
Secondary	To characterize patient utilities following treatment with INRT.	Average patient utilities (derived from EQ-5D) at baseline, 3, 6, 12, 18, 24 and 36 months from the end of treatment.	2 years
Secondary	To determine 2-year overall and progression-free survival following treatment with INRT	Overall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death.; Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death.	2 years
Secondary	To describe the patterns-of-failure following INRT.		2 years