A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00490282
First received: June 21, 2007
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.


Condition Intervention
Head and Neck Cancer
Oropharyngeal Cancer
Radiation: Intensity Modulated Radiation Therapy
Radiation: Adaptive Radiotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Comparison of dosimetry with head and neck (H&N) adaptive radiotherapy (ART) planning relative to standard intensity-modulated radiation therapy (IMRT) planning [ Time Frame: Baseline by standard IMRT plan and adaptive dosing by ART plan evaluated at end of ART at week 6-7. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2007
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Image-Guided Adaptive Radiotherapy
Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)
Radiation: Intensity Modulated Radiation Therapy
IMRT Treatment Over 6-7 Weeks
Other Name: IMRT
Radiation: Adaptive Radiotherapy
ART Treatment Over 6-7 Weeks
Other Name: ART

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.
  2. Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
  3. ECOG performance status 0-2.

Exclusion Criteria:

  1. Patients who have undergone definitive resection of the primary tumor.
  2. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
  3. Prior radiation therapy to the head and neck region.
  4. Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
  5. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
  6. Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 60 ml/min/1.73m2.
  7. Patients who have had prior chemotherapy.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490282

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Adam Garden, MD, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00490282     History of Changes
Other Study ID Numbers: 2006-0947
Study First Received: June 21, 2007
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Oropharyngeal Cancer
Adaptive Radiotherapy
Intensity Modulated Radiation Therapy
IMRT
ART

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014