Neoplasms

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Ear, Nose, and Throat Diseases

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Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Level 0: 46.5 Gy in 15 fractions, 5 fractions/week

Level -1: 52 Gy in 20 fractions, 5 fractions/week

Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)

Hypofractionated intensity modulated radiotherapy

Dominic Moon, MD

This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologically effective dose to 60 Gy in 30 fractions) with concurrent weekly cisplatin.

Standard of care radiation therapy (RT) for head and neck squamous cell carcinoma (HNSCC) involves conventional fractionation delivered over a course of 7 weeks. Although hypofractionated RT (HFRT) delivering higher dose of RT each day over a shorter overall treatment time has been studied and adopted as standard of care in many disease sites including breast and prostate cancers, data on HFRT in HNSCC is limited.

There is a strong radiobiological rationale for HFRT for HNSCC to decrease the overall treatment time and thus the effects of accelerated repopulation in this disease entity. In addition, if similar outcomes can be achieved with a reduced number of fractions, cost effectiveness of care can be improved while minimizing the disruption to the patient's personal and professional lives. A substantial decrease in treatment time may improve compliance and financial toxicity associated with the patient's oncologic treatment.

The global COVID-19 pandemic is highlighting the health risk to society at large of having no viable alternative to a 7 week daily RT course for HNSCC, especially in the setting of compromised immune systems associated with concurrent chemotherapy frequently used in this patient population. Thus, the study of HFRT for HNSCC is both timely and potentially paradigm changing for practices across the United States.

The incidence of human papilloma virus (HPV)-associated oropharynx cancer is increasing in the United States, now accounting for 70-80% of all oropharynx cancers. It has a favorable prognosis vs. non-HPV-associated cancers and studies are ongoing to determine the best strategy to de-intensified therapy while maintaining good oncologic outcomes.

The purpose of this single-arm Phase I study is to assess the tolerability and signal for efficacy of de-intensified HFRT for favorable HPV-associated oropharynx cancer. De-intensification will be achieved in two ways. First, the equivalent biologically effective dose (BED) of HFRT used on trial will be 60 Gy of conventionally fractionationated RT (vs. the current standard of care of 70 Gy). Second, the elective nodal volume irradiated will be limited to involved nodal levels and one immediately adjacent level (vs. the current standard of care of entire bilateral neck nodal regions). Patients will complete RT in 15 fractions (3 weeks) with concurrent weekly cisplatin on dose level 0. If a 3-week regimen is not well-tolerated, a 20 fraction regimen will be used on dose level -1.

Rolling 6 dose finding cohort followed by dose expansion cohort

HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer

HYHOPE: Phase I Study of De-intensified Hypofractionated Radiation Therapy for Human Papilloma Virus-associated Oropharynx Cancer

MD Anderson Dysphagia Inventory (MDADI): 20-100, higher scores mean better quality of life

University of Washington QOL questionnaire (UW-QOL): 0-100, higher scores mean better quality of life

EuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life

Dependence on tube feeds defined as daily use of ≥2 nutritional supplements per day via the feeding tube at the time of evaluation

Gateway for Cancer Research

University of Texas Southwestern Medical Center

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Conventional Fractionated Intensity Modulated Radiotherapy

Hypofractionated Intensity Modulated Radiotherapy

Deborah A. Kuban, MD

The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.

Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.

Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.

Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.

After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.

This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.

A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.

M.D. Anderson Cancer Center

Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks

Arm 1: (CIMRT) Conventional Radiotherapy

Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer	NCT04580446	Human Papilloma... Oropharyngeal C...	Hypofractionate...	18 Years -	University of Texas Southwestern Medical Center
HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer	NCT04580446	Human Papilloma... Oropharyngeal C...	Hypofractionate...	18 Years -	University of Texas Southwestern Medical Center
A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation	NCT00667888	Prostate Cancer	Conventional Fr... Hypofractionate...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hypofractionated intensity modulated radiotherapy