Trial Outcomes & Findings for A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer (NCT NCT00490282)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2020-12-30

Participant Flow

Recruitment Period: June 20, 2007 to November 09, 2010. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Image-Guided Adaptive Radiotherapy Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Image-Guided Adaptive Radiotherapy Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Image-Guided Adaptive Radiotherapy n=25 Participants Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

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

Population: All patients had an original IMRT plan (22) and then either ART 1 (14) or ART2(8) ; Art1 and ART2 were then comparisons of the each ART with the original IMRT. The Measure type Number represents the actual percentage mean dose reduction from the 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.

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

Outcome measures

Outcome measures
Measure	ART1 n=14 Participants Intensity Modulated Radiotherapy (IMRT) + IGRT with one adaptive replan (ART1) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks	ART2 n=8 Participants Intensity Modulated Radiotherapy (IMRT) + IGRT with two adaptive replans (ART2) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning Contralateral Parotid Gland	-2.8 percentage in mean dose reduction	-3.8 percentage in mean dose reduction
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning Ipsilateral Parotid Gland	-3.9 percentage in mean dose reduction	-9 percentage in mean dose reduction

SECONDARY outcome

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

Measure parotid volumes shrinkage for the first adaptive radiotherapy (ART1) replanning for the number of participants at the median trigger point of 16th treatment fraction.

Outcome measures

Outcome measures
Measure	ART1 n=22 Participants Intensity Modulated Radiotherapy (IMRT) + IGRT with one adaptive replan (ART1) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks	ART2 Intensity Modulated Radiotherapy (IMRT) + IGRT with two adaptive replans (ART2) Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks
Number of Participants With Overall Shrinkage of Tumor With Adaptive Radiotherapy (ART)	15 Participants	—

Adverse Events

Image-Guided Adaptive Radiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Garden, MD/Radiation Oncology Department

The University of Texas (UT) MD Anderson Cancer Center

Phone: (713) 563-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place