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

NCT00490282 | Completed Results

• 2 other identifiers: 2006-0947NCI-2012-02092
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Oropharyngeal Cancer

Keywords

Head and Neck Cancer; Oropharyngeal Cancer; Adaptive Radiotherapy; Intensity Modulated Radiation Therapy; IMRT; ART

Outcome Measures

Primary Outcomes (1)

• Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning

  Comparison of mean dose in the Contralateral Parotid Gland and Ipsilateral Parotid Gland change between one adaptive replan (ART1) and two adaptive replans (ART2) planning relative to standard intensity-modulated radiation therapy (IMRT) planning. Dosimetric comparisons was performed using paired t-testing between plans, with patients serving as their own controls. The median trigger point for ART1 was the 16th treatment fraction. For ART2 patients, the median trigger points for the first and second replanning were the 11th and the 22nd fractions, respectively. Percent change in mean dose calculated for each group as 100% (mean post baseline (ART1 or ART2) dosage minus mean baseline IMRT dose for each parotid gland

  Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment

Secondary Outcomes (1)

• Number of Participants With Overall Shrinkage of Tumor With Adaptive Radiotherapy (ART)

  Baseline by IMRT plan and adaptive dosing by ART plan evaluated at the end of the 6-7 week course of treatment

Study Arms (1)

Image-Guided Adaptive Radiotherapy

EXPERIMENTAL

Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)

Radiation: Intensity Modulated Radiation Therapy; Radiation: Adaptive Radiotherapy

Interventions

Intensity Modulated Radiation Therapy RADIATION

IMRT Treatment Over 6-7 Weeks

Also known as: IMRT

Image-Guided Adaptive Radiotherapy

Adaptive Radiotherapy RADIATION

ART Treatment Over 6-7 Weeks

Also known as: ART

Image-Guided Adaptive Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.
• Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Patients who have undergone definitive resection of the primary tumor.
• Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
• Prior radiation therapy to the head and neck region.
• Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
• 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
• Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m2.
• Patients who have had prior chemotherapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Adam Garden, MD/Radiation Oncology Department
• Organization: The University of Texas (UT) MD Anderson Cancer Center

agarden@mdanderson.org

(713) 563-2300

Study Officials

• Adam Garden, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 22, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-12

Locations

US (1)