Randomized Phase 2 Trial of Individualized Adaptive Radiotherapy
Using During-treatment FDG-PET/CT and Modern Technology
in Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Protocol Documents
RTOG 1106/ACRIN 6697 Protocol, Broadcast 02.22.12 [PDF]
Informed Consent-RTOG 1106/ACRIN 6697 [DOC]
Investigator's Brochure: FMISO for PET/CT, version November 2009 [PDF]
Protocol Principal Investigators:
Feng-Ming (Spring) Kong, MD, PhD
RTOG 1106 Principal Investigator
Daniel Pryma, MD
ACRIN 6697 Principal Investigator
Status: Open
Overview:
The RTOG 1106/ACRIN 6697 clinical trial is evaluating if during the course
of radiotherapy (RT) treatment information gained from a FDG-PET/CT scan
can facilitate individualized adaptive therapy in patients with inoperable
stage-III non–small-cell lung cancer (NSCLC).
Please note: Participating sites must be RTOG member institutions and ACRIN approved.
Main Objectives:
RTOG 1106: To determine whether tumor dose can be escalated to improve
the freedom from local-regional progression (LRPF) rate at 2 years when an
individualized adaptive RT plan is applied by the use of a FDG-PET/CT scan
acquired at 40-46 Gy initial dose of RT in patients with inoperable or unresectable
stage III NSCLC
ACRIN 6697: To determine whether the relative change in SUVpeak from the
baseline to the during-treatment FDG-PET/CT, defined as (during-treatment
SUVpeak – baseline SUVpeak)/baseline SUVpeak x 100%, can predict the LRPF
with a 2-year follow up.
Participants:
Patients must be > 18 and have FDG-avid (maximum SUV ≥ 4.0) and histologically
or cytologically proven non-small cell lung cancer.
Study Design:
The primary objective of RTOG 1106/ACRIN 6697 is to determine whether tumor
dose can be escalated to improve the "freedom from local-regional progression" rate after
two years of treatment using FDG-PET/CT scans to individualize adaptive RT plans.
All participants will undergo a baseline FDG-PET/CT scan as part of their treatment planning.
Participants in both arms will receive RT once a day 5 days a week for 6 weeks. After 4 weeks
of treatment, participants of both arms will undergo a second FDG-PET/CT scan. Participants
in the experimental arm will have the RT planning modified to provide as high a dose as
possible to the residual metabolically active tumor while keeping doses to normal lung
tissue constant (mean lung dose of 20 Gy) and doses to other adjacent organs within
safe limits whereas participants in the control arm will complete the initial treatment as planned.
In a subset of the study’s participants, 18F-fluoromisonidazole (FMISO)-PET/CT will be conducted
at baseline to identify the presence of hypoxia, which inhibits the production of the oxygen-free
radicals that cause radiation to damage DNA and to kill tumor cells. The trial will test the use of
imaging to identify hypoxic areas and to target those areas with higher levels of radiation. The
important question is whether areas of hypoxia identified at baseline will contain residual disease
at mid-treatment stage since it’s the slowest to die off.