Clinical trial NCT03403465: Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Official title: Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers ( Adaptive PET II)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer of the Cervix
Vulvar Cancer
Esophageal Cancer
Anal Canal Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of subjects with benefit from an intra-treatment PET-CT
timeFrame: 4 years
measure: Pathologic complete response
timeFrame: 4 years
measure: Locoregional control
timeFrame: Day of intra treatment PET-CT/ approx 2-4 hours
measure: Freedom from distant metastases
timeFrame: 4 years
measure: Measure overall survival (OS)
timeFrame: 4 years
measure: Progression free survival (PFS)
timeFrame: 4 years
Secondary outcomes:
measure: Measure the potential sparing of radiation dose to critical normal tissue
timeFrame: 4 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Junzo Chino, MD
role: PRINCIPAL_INVESTIGATOR
References: