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Dosimetric and Clinical Outcomes of Hyaluronic Acid Spacer in Phase II Randomized Controlled Trial in Cervical Cancer

Dosimetric and Clinical Outcomes of Hyaluronic Acid Spacer in Phase II Randomized Controlled Trial in Cervical Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210929004
Enrollment
38
Registered
2021-09-29
Start date
2021-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with locally advanced cervical cancer treated with definitive (chemo)radiation cervical cancer hyaluronic acid spacer rectal toxicity

Interventions

At the time of first brachytherapy, hyaluronic acid 6-10 ml will be injected between the rectum and cervix at the posterior wall of the vagina with transrectal ultrasound guidance. ,No hyaluronic acid
Experimental Drug,No Intervention No treatment
Hyaluronic acid spacer,Standard treatment

Sponsors

Ratchadapiseksompotch Research Fund
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Positive biopsy showing squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix 2. Cancer of the cervix is considered suitable for curative treatment with definitive radio-(chemo)therapy

Exclusion criteria

Exclusion criteria: 1. Posterior vaginal involvement 2. Other primary malignancies except basal cell carcinoma of the skin 3. Small cancer neuroendocrine cancer, melanoma, and other rare cancers in the cervix 4. Rectal invasion 5. Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace 6. Previous pelvic or abdominal radiotherapy 7. Previous total or partial hysterectomy 8. Contraindications to MRI 10. Coagulopathy

Design outcomes

Primary

MeasureTime frame
Dosimetric data of the rectum At the RT completion D2cc of the rectum

Secondary

MeasureTime frame
Acute toxicity incidence During treatment and at 3 months after RT CTCAE version 5.0,Late toxicity incidence at 6 months, 12 months and 24 months after RT CTCAE version 5.0,Quality of life At time of RT completion and 12 months after RT EORTC QLQ-C30, CX24

Countries

Thailand

Contacts

Public ContactNapapat Amornwichet

Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chulalongkorn University

Napapat.amornwichet@gmail.com022564334

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026