Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers

Brief Title

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)

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

The number of subjects with benefit from an intra-treatment PET-CT

Secondary Outcome

 Measure the potential sparing of radiation dose to critical normal tissue

Condition

Cancer of the Cervix

Intervention

FDG PET scan

Study Arms / Comparison Groups

 Single arm interventional study

Description:  Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

130

Start Date

March 27, 2018

Completion Date

September 2023

Primary Completion Date

September 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Junzo Chino, MD, 919 668 3726, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03403465

Organization ID

Pro00089619

Responsible Party

Sponsor

Study Sponsor

Duke University

Study Sponsor

Junzo Chino, MD, Principal Investigator, Duke University

Verification Date

December 2020