Last updated: April 4, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting
Phase
N/A
Condition
Vaginal Atrophy
Treatment
UCSD Vaginal Dilator Questionnaire
EORTC Sexual Health Questionnaire
Clinical Study ID
NCT05002751
QRIVS-001
PAR 20-292
Ages 18-99 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stagesIIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALNnodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsyor 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 whodo not receive therapeutic anticoagulation; patients receiving therapeuticanticoagulation, such as low-molecular-weight heparin or warfarin, should be on astable dose.)
- Age is > 18 years.
- Patient does not have a known allergy to cisplatin or compounds of similar biologiccomposition.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients positive for human immunodeficiency virus (HIV) are allowed on study, butHIV-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 ofopportunistic infections
- A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standardPCR-based tests.
Exclusion
Exclusion Criteria:
- 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 organtransplantation.
- 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 (withthe exception of DCIS of the breast, or early stage basal cell carcinoma of the skin) a. transcription mediated amplification (TMA) or branched DNA testing.
- History or risk of autoimmune disease, including but not limited to systemic lupuserythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosisassociated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's
Study Design
Total Participants: 12
Treatment Group(s): 2
Primary Treatment: UCSD Vaginal Dilator Questionnaire
Phase:
Study Start date:
October 06, 2022
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
UCSD Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
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