Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.

Polyethylene Glycol Hydrogel

Jing Zeng

This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.

PRIMARY OBJECTIVES:

I. To utilize the TraceIT hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (TURBT).

II. To improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers.

SECONDARY OBJECTIVES:

I. To report adverse events surrounding the placement of the TraceIT tissue marker.

II. To calculate the actual dose received by the bladder tumor bed, as delineated by the hydrogel.

III. To compare the dosimetric impact to the tumor bed of daily patient alignment to the pelvic bones, versus alignment to the whole bladder, versus alignment to the hydrogel markers.

IV. To calculate the amount of normal tissue radiation dose decrease achievable without losing tumor coverage, with better tumor targeting with hydrogel placement.

OUTLINE:

Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.

TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer

TraceIT TM Hydrogel Tissue Marker for Patients Receiving Definitive Chemoradiation for Bladder Cancer

Daily changes will be compared across the patient group as well as within each subjects' treatment course.

Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient.

Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on alignment to the hydrogel location, versus alignment to whole bladder location, versus alignment to bony anatomy.

Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on hydrogel location. Total radiation dose to the PTV can then be calculated as the sum of the daily dose.

Graded by the Common Terminology Criteria in Adverse Events version 4.0

Daily pre-radiation imaging will be used to identify the smallest setup margin required for consistent coverage of the GTV, which is likely smaller than the current standard of care setup margin of at least 2 cm around the GTV.

National Cancer Institute (NCI)

University of Washington

Associate Professor, Department of Radiation Oncology

Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.

Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection

Supportive Care (TracelT Hydrogel)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Jing Zeng

Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.

Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates

Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates

Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym

Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location

Number of Participants With Adverse Events Caused by Hydrogel

The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.

Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)

Overall Study

Skin and Connective Tissue Diseases

Wounds and Injuries

Dermatitis

Breast Neoplasms

Head and Neck Neoplasms

Radiodermatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Breast Diseases

Radiation Injuries

Anti-Inflammatory Agents

All Drugs and Chemicals

Dermatologic Agents

Anti-Infective Agents

Herbal and Botanical

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Petrolatum

Mineral Oil

Sulfadiazine

Silver Sulfadiazine

Emollients

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Anti-Infective Agents, Local

Calendula

Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

Patients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

Calendula Ointment

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Silicone-based Film Forming Topical Gel

Topical Hydrocortisone

Josh Walker, M.D., Ph.D.

This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.

PRIMARY OBJECTIVE:

I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance.

SECONDARY OBJECTIVES:

I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care.

EXPLORATORY OBJECTIVES:

I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance.

III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

After completion of study, patients are followed up at 6 days and 3 weeks post-RT.

StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients

A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis

Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.

Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer	NCT03125226	Bladder Carcino...	Polyethylene Gl...	18 Years -	University of Washington
StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients	NCT05073172	Breast Carcinom... Head and Neck C... Radiation-Induc...	Calendula Ointm... Petrolatum-Mine... Polyethylene Gl... Silicone-based ... Silver Sulfadia... Topical Hydroco...	18 Years -	OHSU Knight Cancer Institute

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