Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003482
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Cristiane Takita, MD, University of Miami

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Radiation: Postop IMRT for head/neck cancer Device: CT for Radiation Treatment Planning

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Actual Study Start Date : May 9, 2006
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Postop IMRT for Head/Neck cancer
CT for Radiation Treatment Planning
Radiation: 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.
Other Name: IMRT

Device: 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
Other Name: CT Simulation

Chemo/IMRT for bulky Head/Neck cancer
CT for Radiation Treatment Planning
Radiation: 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.
Other Name: IMRT

Device: 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
Other Name: CT Simulation




Primary Outcome Measures :
  1. Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients [ Time Frame: 7 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer [ Time Frame: 7 weeks ]
    To determine whether patients undergoing standard IMRT for head and neck cancers require re-planning during the course of therapy, due to volumetric or dosimetric changes.

  2. Length of Time Required for Replanning of Radiation Therapy [ Time Frame: 7 weeks ]
    To estimate what the appropriate time course should be for re-planning of radiation therapy if it is deemed necessary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003482


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Cristiane Takita, MD University of Miami
Layout table for additonal information
Responsible Party: Cristiane Takita, MD, Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02003482    
Other Study ID Numbers: 20060212
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Cristiane Takita, MD, University of Miami:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Intensity modulated radiation therapy
IMRT
Anatomic Changes
Postoperative
Unresectable
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site