Early and locally advanced cervical cancer with intact cervix Hypofractionated whole pelvic concurrent chemoradiotherapy Indirect Excess Dose Volume Ratio (iRex) - optimized Image Guided Adaptive Brachytherapy (iRex-IGABT) cervical cancer, uterine Hypofractionation, Radiotherapy Dose Brachytherapy Indirect Excess Dose Volume Ratio (iRex)
Conditions
Interventions
Hypofractionated IMRT/VMAT 44Gy/20F followed by iRex-oriented IGABT,Hypofractionated IMRT/VMAT 44Gy/20F followed by D2cc-oriented IGABT,Conventional IMRT/VMAT 45Gy/25F followed by iRex-oriented IGA
Experimental Radiation,Experimental Radiation,Experimental Radiation,Active Comparator Radiation
HYPO-iRex,HYPO-D2cc,CVRT-iRex,CVRT-D2cc
Sponsors
Faculty of Medicine, Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT 2. Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix 3. Staging according to FIGO 2018 and TNM guidelines 4. MRI of the pelvis at diagnosis is performed 5. MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed 6. MRI with the applicator in place at the time of (first) BT will be performed 7. GFR >/= 50 mL/min 8. Patient informed consent
Exclusion criteria
Exclusion criteria: 1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin 2. Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix 3. Metastatic disease at, above, and beyond the common iliac node or 3 any pathologic nodes or more. 4. Previous pelvic or abdominal radiotherapy 5. Previous total or partial hysterectomy 6. Combination of preoperative radiotherapy with surgery 7. Patients receiving BT only 8. Patients receiving EBRT only 9. Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2). 10. Contra-indications to MRI 11. Contra-indications to BT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity incidence during treatment; and at 1- and 3-month follow up after treatment CTCAE ,Chronic toxicity incidence at 6-, 12-month, and 3-, 5-year follow up after treatment CTCAE | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate post-EBRT period; and at 3-, 6-, and 12-month follow up after treatment RECIST 1.1,Quality of life during treatment; and at 1-, 3-, 6-, 12-month, and 3-, 5-year follow up after treatment EORTC QLQ-C30, CX24, EN24,Local and nodal recurrence free, metastatic free, disease-specific, and overall survival rate at 3-, 5-year follow up after treatment Clinical exam and abdominopelvic CT/MRI as clinically indicated,Dosimetric data of EBRT and IGABT after radiation delivery Dose reports in treatment planning system,Number of fractions with successful iRex optimization after radiation delivery Dose reports in treatment planning system | — |
Countries
Thailand
Contacts
Public ContactTissana Prasartseree
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Outcome results
None listed