Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer

NCT ID: NCT02003482

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-09
• Study Completion Date: 2018-03-26

Brief Summary

Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.

Detailed Description

The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Postop IMRT for Head/Neck cancer

CT for Radiation Treatment Planning

Postop IMRT for head/neck cancer

Intervention Type: RADIATION

Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.

CT for Radiation Treatment Planning

Intervention Type: DEVICE

Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment

Chemo/IMRT for bulky Head/Neck cancer

CT for Radiation Treatment Planning

Postop IMRT for head/neck cancer

Intervention Type: RADIATION

Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.

CT for Radiation Treatment Planning

Intervention Type: DEVICE

Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment

Interventions

Postop IMRT for head/neck cancer

Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.

Intervention Type: RADIATION

CT for Radiation Treatment Planning

Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment

Intervention Type: DEVICE

Other Intervention Names

IMRT; CT Simulation

Eligibility Criteria

Inclusion Criteria

• AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:

• If gross total resection is performed it must be completed within 7 weeks of registration
• Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
• Pretreatment evaluations required for eligibility include:

• History and physical examination within four weeks prior to study entry
• Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation
• Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment
• Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required
• Patients must be ≥ 18 years of age.
• Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
• Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in accordance with local regulations, whichever is more sensitive).
• Patients must sign a study-specific informed consent form prior to registration.

Exclusion Criteria

• Histology positive for melanoma.
• Gross (visible or palpable) disease left after surgery.
• Less than gross total resection or patients requiring staged surgery.
• Prior head and neck radiotherapy.
• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Cristiane Takita, MD

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristiane Takita, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20060212

Identifier Type: -

Identifier Source: org_study_id