Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
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.
Conditions:
🦠 Cancer of the Cervix 🦠 Vulvar Cancer 🦠 Esophageal Cancer 🦠 Anal Canal Cancer
🗓️ Study Start (Actual) 27 March 2018
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2024
👥 Enrollment (Estimated) 130
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 January 2018
  • First Submitted that Met QC Criteria 11 January 2018
  • First Posted 18 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 September 2023
  • Last Update Posted 15 September 2023
  • Last Verified September 2023