Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Xerostomia

Oropharyngeal Neoplasms

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.

radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.

standard radiotherapy

radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy

experimental radiotherapy

Melissa Knutsen, MPH

Tuvara King

Colette Shen, MD

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.

This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer

The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.

The mass of generated saliva post-radiation treatment will be measured.

The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores.

The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.

xerostomia will be assessed using The National Cancer Institute Common Terminology Criteria for Adverse Events is a descriptive terminology (NCI-CTCAE) v5.0 that can be utilized for Adverse Event (AE) reporting.

A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

UNC Lineberger Comprehensive Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Tomotherapy Treatment Planning

Don Yee, MD

Standard treatment for non-operable cervix cancer is radiation and chemotherapy. This treatment combination can result in significant radiation side-effects involving the bladder, small bowel and rectum. To improve results with radiation/chemotherapy, higher radiation doses have been tried for cervix cancer patients. Results from using higher radiation doses show that cervix tumours may be better controlled, but the radiation side-effects are worsened. Intensity modulated radiotherapy (IMRT) and Tomotherapy are new radiation planning and delivery technologies which may allow for delivery of higher radiation doses with less damage to normal organs. The purpose of this project is to determine whether or not IMRT and/or Tomotherapy technology can produce radiation plans that deliver higher doses of radiation to the tumor and lower doses to normal organs when compared to standard radiation plans. The results from this project will provide the basis for possibly treating future cervix cancer patients with Tomotherapy and providing them with improved cure rates along with decreased rates of radiation side effects. No patients will be treated on this protocol, as the investigators plan to only compare radiation dose calculations from different treatment plans created for test cervix cancer cases. There will be absolutely no patient contact in this protocol.

Background Information:

The addition of concurrent chemotherapy to radiotherapy (RT) for locally-advanced cervix cancer has improved patient outcomes, but treatments are associated with significant rates of radiotherapy (RT)-related toxicities. Plus, the disease-free and overall survival benefits conferred by concurrent chemotherapy appear to be most prominent in patients with earlier stage disease. Limits to RT for cervix cancer which can impact patient outcomes are overall treatment time and RT dose. Attempts to overcome these limits have been made in trials using altered RT fractionation schemes. Promising rates of local control reported in these trials are offset by excessive rates of acute and late RT-related toxicities.

Intensity-modulated radiotherapy (IMRT) is innovative RT planning and delivery technology with the ability to vary the intensity of radiation across a beam, allowing for increased conformity of RT dose around target volumes along with decreased dose delivered to normal structures. Tomotherapy uses an intensity-modulated beam which rotates around the patient as the patient is being translated longitudinally through the gantry and features the ability to acquire megavoltage CT (MVCT) images of target structures at each treatment. It is thought that Tomotherapy can plan and deliver more conformal RT with the added advantage of daily assessment of target and critical structure position via MVCT imaging.

Experience with using IMRT for cervix cancer is sparse. Reports of treating pelvic nodal targets in small numbers of selected cervix cancer patients with IMRT suggests that the treatments are tolerable and associated with decreased incidences of acute and late RT-related toxicities compared with a similar patient cohort treated with conventional RT technologies. Currently, there is no published report of using Tomotherapy to plan or deliver RT using conventional or altered fractionation for cervix cancer patients.

The limitations of overall treatment time and the maximal dose of RT that can be safely delivered to the pelvis targets make cervical carcinoma a tumor in which Tomotherapy can potentially improve the therapeutic ratio. Tomotherapy's ability to deliver more conformal RT to target structures and minimize dose to normal structures may allow for delivery of altered fractionation radiation plans for cervix cancer with acceptable rates of RT-related toxicities. Tomotherapy allows for delivery of differential daily doses of RT to target volumes that lie within larger target volumes which in effect delivers a simultaneous integrated boost (SIB) to areas of gross disease which lie within a larger volume at risk for harbouring micrometastases. Delivery of the boost dose of radiation in a simultaneous as opposed to sequential fashion decreases the overall RT treatment time which theoretically reduces the effects of accelerated tumor cell repopulation. Delivering higher doses per fraction to areas of gross disease would theoretically increase the radiobiologic enhancement effects of concurrent cisplatin chemotherapy.

Tomotherapy represents a key advance in radiotherapy planning and delivery technology. Its potential dosimetric and radiobiologic advantages over standard radiotherapy technologies need evaluation in properly-conducted clinical trials. Prior to the initiation of such trials, it must be shown that Tomotherapy plans at least have dosimetric advantages over conventional plans.

Objective:

To compare radiotherapy (RT) plans created for locally-advanced cervix cancer cases using Tomotherapy, conventional computed tomography-based methods and step-and-shoot intensity-modulated methods.

Study Design:

Pre-treatment planning computed tomography scans of ten previously-treated cervix cancer patients will be used. All identifying patient data on these CT image sets will be completely removed. Three RT plans will be created for case: Tomotherapy, step-and-shoot IMRT, and conventional. The University Medical Centre in Utrecht, The Netherlands has implemented IMRT into clinical management of cervical cancer and the Gynecologic Oncology group there has graciously agreed to collaborate on this project by creating optimized step-and-shoot IMRT plans on our ten test cases. The anonymous CT image sets will be stored on data discs which will be sent via bonded courier to the University Medical Centre in Utrecht, The Netherlands for generation of step and shoot IMRT plans. Data to be calculated and collected from all plans include: dose-volume histograms (DVH's) for all target volumes and critical structures. Tumor Control Probability for targets and Normal Tissue Complication Probability for critical structures will be calculated. RT plans created on this protocol will only be used for dose and biophysical model calculation comparisons; no plan will be used to deliver actual radiation treatments to any patient. There will be absolutely no patient contact or interaction on this protocol.

Future Directions:

The investigators anticipate that results from this study will confirm the hypothesis that Tomotherapy plans incorporating a simultaneous integrated boost for cervix cancer will provide superior target volume coverage and normal critical structure avoidance when compared with step-and-shoot IMRT and conventional plans. Such confirmation will provide the basis to proceed with efforts to improve target and normal structure delineation for Tomotherapy treatment planning of cervix cancer using MRI-based planning. Ultimately, we plan to initiate phase I/II trials using MRI-based Tomotherapy planning and delivery techniques for cervix cancer patients. Incorporation of RT dose escalation and monitoring of treatment response with biologic imaging techniques for cervix cancer patients treated with Tomotherapy are other future potential areas of investigation.

Comparison of Tomotherapy Versus Intensity-modulated Step-and-shoot and Conventional Radiation Treatment Plans for Patients With Locally-advanced Squamous Cell Carcinoma of the Cervix

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia	NCT06276946	Oropharynx Canc... Head and Neck C... Xerostomia	standard radiot... experimental ra...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Comparison of Tomotherapy Versus Intensity-modulated Step-and-shoot and Conventional Radiation Treatment Plans for Patients With Locally-advanced Squamous Cell Carcinoma of the Cervix	NCT00124488	Cervix Neoplasm	Tomotherapy Tre...	18 Years -	AHS Cancer Control Alberta

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