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

Learn more about:
Related Clinical Trial
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

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 Information


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

Administrative Informations


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