Summary

Eligibility
for females ages 18-99 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Jyoti Mayadev, MD
Photo of Jyoti Mayadev
Jyoti Mayadev

Description

Summary

Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, we will use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.

Official Title

Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device

Details

This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis. The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.

Keywords

Vaginal Stricture Vaginal Stenosis Radiotherapy Side Effect Brachytherapy Side Effect Constriction, Pathologic

Eligibility

You can join if…

Open to females ages 18-99

  • Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes ≥2,500/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
  • total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) ≤3 × ULN
  • alkaline phosphatase ≤2.5 × ULN
  • creatinine <1.5 mg/dL INR and aPTT ≤1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)
  • Age is > 18 years.
  • Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients positive for human immunodeficiency virus (HIV) are allowed on study, but

HIV-positive patients must have:

  • A stable regimen of highly active anti-retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.

You CAN'T join if...

  • Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.
  • Patients with PALN nodal metastasis above the T12/L1 interspace.
  • Patients who had a radical hysterectomy with positive PALNs are not eligible.
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
  • Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)
  • transcription mediated amplification (TMA) or branched DNA testing.
  • History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's

Location

  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Jyoti Mayadev, MD
    Professor Of Clinical, Radiation Medicine and Applied Science. Authored (or co-authored) 45 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05002751
Study Type
Observational
Last Updated