Endometrial Neoplasms, Uterine Cervical Neoplasm
Conditions
Keywords
Uterine Cervical Neoplasm, Endometrial Neoplasms, Online Adaptive Radiotherapy, Adjuvant Radiotherapy
Brief summary
Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.
Detailed description
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).
Interventions
RADIATIONOnline adaptive radiotherapy
PTV with 5 margins covers CTV
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment. 2. Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB). 3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe. 4. Karnofsky score ≥ 70. 5. Subjects aged ≥ 18 years and ≤ 70 years. 6. No evidence of para-aortic metastatic lymph nodes. 7. No contraindications to CT scanning. 8. Subjects must be able to cooperate in completing the entire study. 9. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L. 10. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).
Exclusion criteria
1. Subjects who have received prior pelvic radiotherapy. 2. Subjects with other primary malignancies. 3. Subjects with contraindications to radiotherapy, as determined by the investigators. 4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance. 5. Active infection with fever. 6. Active inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician-reported acute toxicity | From the start of treatment to 3 months after treatment | Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme | 3-year | Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme |
| The dose coverage of target volume as assessed by planing tumor volume V100% | Through study completion, an average of five month | Planing tumor volume V100%, defined as the planing tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume. |
| Target automatically contouring accuracy | Through study completion, an average of five month | For every target in each fraction, the evaluation of accuracy for target contouring are categorized as follow: no edits, minor edits, moderate edits, major edits and not applicable. |
| Organs at risk contouring accuracy | Through study completion, an average of five month | For every organs at risk in each fraction, the evaluation of accuracy for organs at risk contouring are categorized as follows: no edits, minor edits, moderate edits, major edits and not applicable. |
Countries
China
Contacts
STUDY_CHAIRFuquan Zhang, M.D.
Peking Union Medical College Hospital
Outcome results
None listed