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

NCT02003482 | Completed

• 1 other identifier: 20060212
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Intensity modulated radiation therapy; IMRT; Anatomic Changes; Postoperative; Unresectable

Outcome Measures

Primary Outcomes (1)

• Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients

  To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.

  7 weeks

Secondary Outcomes (2)

• Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer

  7 weeks

• Length of Time Required for Replanning of Radiation Therapy

  7 weeks

Study Arms (2)

Postop IMRT for Head/Neck cancer

CT for Radiation Treatment Planning

Radiation: Postop IMRT for head/neck cancer; Device: CT for Radiation Treatment Planning

Chemo/IMRT for bulky Head/Neck cancer

CT for Radiation Treatment Planning

Radiation: Postop IMRT for head/neck cancer; Device: CT for Radiation Treatment Planning

Interventions

Postop IMRT for head/neck cancer 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.

Also known as: IMRT

Chemo/IMRT for bulky Head/Neck cancer; Postop IMRT for Head/Neck cancer

CT for Radiation Treatment Planning 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

Also known as: CT Simulation

Chemo/IMRT for bulky Head/Neck cancer; Postop IMRT for Head/Neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pathologic stage I-IV cancers of the head and neck (site of tumor origin nasopharynx, parotid, oral cavity, oropharynx, larynx, or hypopharynx,) either following gross total resection and requiring postoperative XRT for high-risk features or undergoing definitive concurrent chemo-radiation.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Cristiane Takita, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: May 9, 2006
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)