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

Phase 2

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

• Registration Number: TCTR20210929004
• Lead Sponsor: Ratchadapiseksompotch Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Study Completion: 2022-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 38

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosimetric data of the rectum At the RT completion D2cc of the rectum

Secondary Outcome Measures

Name	Time	Method
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