Trial Title:
Hypofractionated Preoperative Radiation for Head and Neck Cancers (HyPR-HN)
NCT ID:
NCT05538533
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Head and Neck Cancer
Hypofractionated Preoperative Radiation
Time-to-Event Continuous Reassessment Methodology
TITE-CRM
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This study will use a time-to-event continual reassessment method (TITE-CRM) for
assigning subjects to the radiation therapy dosages.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
46 Gy Radiation Therapy
Description:
Dose per fraction of 4.6.
Arm group label:
46 Gray (Gy)
Intervention type:
Radiation
Intervention name:
40 Gy Radiation Therapy
Description:
Dose per fraction 5.7.
Arm group label:
40 Gray (Gy)
Intervention type:
Radiation
Intervention name:
35 Gy Radiation Therapy
Description:
Dose per fraction 7.0.
Arm group label:
35 Gray (Gy)
Summary:
This is a phase 1 study to determine the safety of a condensed preoperative radiation
regimen (10, 7, or 5 fractions) for the management of head and neck squamous cell
carcinoma.
Detailed description:
All subjects in this study will receive hypofractionated adjuvant radiation therapy,
which will be subject to fractionation reduction, that being 10 fractions, 7 fractions,
or 5 fractions, as compared to 30 fractions of conventional radiation therapy.
The subjects will receive smaller number of fractions (total visits) but with a higher
dose of radiation. Participants will receive a total radiation dose of 46 Gy in 10
fractions (Dose Level 1), 40 Gy in 7 fractions (Dose Level 2), or 35 Gy in 5 fractions
(Dose Level 3), depending on the assigned experimental total fractions. Radiation will be
delivered using intensity modulated radiation therapy (IMRT) with a daily cone-beam CT
for five days a week, for less than two weeks depending on the assigned dose level at the
time of enrollment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients 18 years or older with surgically resectable, Human papillomavirus (HPV)
-negative squamous cell carcinoma of the head and neck (squamous cell carcinoma of
the larynx, hypopharynx, oropharynx, oral cavity, nasal cavity or paranasal
sinuses). Resectability will be determined by the treating surgeon. Patients must
have locoregionally advanced disease defined by clinical T3-4 staging and/or
clinical node positive staging. Patients may also be eligible if they meet one of
the following criteria:
1. Clinical T2N0 disease with perineural invasion identified on a pretreatment
biopsy.
2. Clinical T2N0 disease with lymphovascular space invasion identified on a
pretreatment biopsy.
3. Clinical T2N0 oral cavity cancer with clinical, biopsy, or radiographic depth
of invasion of at least 5 mm.
2. Zubrod performance status 0-2.
3. Patients must have the psychological ability and general health that permits
completion of the study requirements and required follow-up.
4. Inclusion of COVID-19 positive patients will be based on standard institutional
protocol.
5. Female patients must meet one of the following:
- Postmenopausal for at least one year before the screening visit, OR
- Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy),
OR
- If subject is of childbearing potential (defined as not satisfying either of
the above two criteria), agrees to practice two acceptable methods of
contraception (combination methods require use of two of the following:
diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge,
male or female condom, hormonal contraceptive) from the time of signing of the
informed consent form through 90 days after the last dose of study agent, AND
- Agrees to practice true abstinence when this is in line with the preferred and
usual lifestyle of the subject. (Periodic abstinence [e.g., calendar,
ovulation, symptom-thermal, postovulation methods] and withdrawal are not
acceptable contraception methods).
6. Male patients, even if surgically sterilized (i.e., status post vasectomy), must
agree to one of the following:
- Practice effective barrier contraception during the entire study period and
through 60 calendar days after the last dose of study agent, OR
- Must also adhere to the guidelines of any study-specific pregnancy prevention
program, if applicable, OR
- Agree to practice true abstinence when this is in line with the preferred and
usual lifestyle of the subject. (Periodic abstinence [e.g., calendar,
ovulation, symptom-thermal, postovulation methods] and withdrawal are not
acceptable methods of contraception.
7. Ability to understand a written informed consent document, and the willingness to
sign it.
Exclusion Criteria:
1. Radiographic evidence of extranodal extension.
2. Patients with laryngeal involvement who are candidates for non-surgical laryngeal
preservation as deemed by a surgeon and/or radiation oncologist. These patients
include, but are not limited to, those with T1-T3 laryngeal cancer who do not have
pretreatment tracheostomy and/or feeding tube or those with base of
tongue/hypopharyngeal cancers with laryngeal involvement without cartilage invasion
or pretreatment tracheostomy and/or feeding tube.
3. HPV-positive squamous cell carcinoma.
4. Prior invasive malignancy within the past three years (except for non-melanomatous
skin cancer, and early stage treated prostate cancer).
5. Life expectancy less than 12 months.
6. Zubrod performance status ≥ 3.
7. Patients with prior radiation therapy to the head and neck (Note: Prior external
beam radiotherapy is excluded, but iodine-131 is allowed).
8. Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy,
or immune therapy for the study cancer.
9. Body weight ≤ 30 kg.
10. Any of the following severe laboratory abnormalities within 14 days of registration,
unless corrected prior to it: sodium < 130 mmol/L or > 155 mmol/L; potassium < 3.5
mmol/L or > 6 mmol/L; fasting glucose < 40 mg/dL or > 400 mg/dL; serum calcium
(ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL; magnesium < 0.9 mg/dL
or > 3 mg/dL.
11. Unstable angina and/or congestive heart failure requiring hospitalization within
three months prior to step 1 registration.
12. Transmural myocardial infarction within three months prior to step 1 registration.
13. Medical or psychiatric illness which would compromise the patient's ability to
tolerate treatment or limit compliance with study requirements.
14. Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception during treatment and
for six months after radiation, this exclusion is necessary because the treatment
involved in this study may be significantly teratogenic. Women who are breastfeeding
are also excluded.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Froedtert Hospital and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Medical College of Wisconsin Cancer Center Clinical Trials Office
Phone:
866-680-0505
Phone ext:
8900
Email:
cccto@mcw.edu
Contact backup:
Last name:
Joseph Zenga, MD
Email:
jyzenga@mcw.edu
Investigator:
Last name:
Joseph Zenga, MD
Email:
Principal Investigator
Start date:
January 6, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Medical College of Wisconsin
Agency class:
Other
Source:
Medical College of Wisconsin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538533
