Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | March 27, 2018 |
| End Date: | February 2021 |
| Contact: | Bijal Shah, MS |
| Email: | bijal.shah@duke.edu |
| Phone: | 919 6683726 |
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers ( Adaptive PET II)
This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the
utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in
many malignant diseases as a curative treatment modality. However, critical normal tissue is
often in close approximation to disease, and portions of such tissue must receive high doses
of radiation for appropriate treatment.
Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current
protocol, may allow for a means of determining the eventual response to therapy, at a time
point when adaptation of treatment plan may be possible to improve outcomes. This protocol
will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that
evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The
current focus will be more specific to certain types of gastrointestinal and gynecologic
cancers treated with RT, identified from the prior study to warrant further research.
utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in
many malignant diseases as a curative treatment modality. However, critical normal tissue is
often in close approximation to disease, and portions of such tissue must receive high doses
of radiation for appropriate treatment.
Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current
protocol, may allow for a means of determining the eventual response to therapy, at a time
point when adaptation of treatment plan may be possible to improve outcomes. This protocol
will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that
evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The
current focus will be more specific to certain types of gastrointestinal and gynecologic
cancers treated with RT, identified from the prior study to warrant further research.
Intra-treatment PETs have only recently been studied in small pilot series. In rectal cancer,
a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of
neoadjuvant chemoradiotherapy was able to discriminate sub-optimal responders with a
sensitivity of 94% and an accuracy of 78%, though the most useful metric was a novel "visual
response score" based on interpreting radiologists scoring rather than more established
objective data available from PET, like SUV. A study from China in non-small cell lung cancer
found that decreases in SUV and MTV on intra-treatment PET-CTs after 40Gy of chemoradiation
therapy were significantly greater in patients responding to treatment by post-treatment
RECIST criteria. For head and neck cancers, a Belgian study found that intra-treatment SUVmax
at 47Gy was associated with significant differences in overall survival. Therefore, there is
emerging evidence that an intra-treatment PET may also be of significant prognostic utility,
at an early enough time point to potentially alter treatment accordingly.
All participants will be required to complete two research PET scans in addition to standard
of care planning CT's for radiation therapy. For all subjects with cancer of the cervix and
vulva an intra-treatment PET-CT will be obtained and used to develop a volume adaptive
treatment plan for the remainder of the course. Subjects with esophageal and anal canal
cancer will have an adapted plan if the treating radiation oncologist determines an adapted
plan is clinically relevant.
a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of
neoadjuvant chemoradiotherapy was able to discriminate sub-optimal responders with a
sensitivity of 94% and an accuracy of 78%, though the most useful metric was a novel "visual
response score" based on interpreting radiologists scoring rather than more established
objective data available from PET, like SUV. A study from China in non-small cell lung cancer
found that decreases in SUV and MTV on intra-treatment PET-CTs after 40Gy of chemoradiation
therapy were significantly greater in patients responding to treatment by post-treatment
RECIST criteria. For head and neck cancers, a Belgian study found that intra-treatment SUVmax
at 47Gy was associated with significant differences in overall survival. Therefore, there is
emerging evidence that an intra-treatment PET may also be of significant prognostic utility,
at an early enough time point to potentially alter treatment accordingly.
All participants will be required to complete two research PET scans in addition to standard
of care planning CT's for radiation therapy. For all subjects with cancer of the cervix and
vulva an intra-treatment PET-CT will be obtained and used to develop a volume adaptive
treatment plan for the remainder of the course. Subjects with esophageal and anal canal
cancer will have an adapted plan if the treating radiation oncologist determines an adapted
plan is clinically relevant.
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar,
esophageal and anal canal cancer
Patients with local or regional nodal disease are eligible
Zubrod Performance Status 0, 1, or 2
Age ≥ 18
Negative serum pregnancy test for women of child bearing potential
Patient must sign study-specific informed consent prior to study entry
Exclusion Criteria:
No gross disease visible on imaging at the start of radiotherapy
Contraindication to PET
Complete response by PET achieved with pre-radiation therapy treatment (surgery or
chemotherapy)
Breast feeding
Positive serum pregnancy test
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