Clinical trial · Interventional
Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
A Prospective Study to Evaluate Optimal Margin of Iterative Cone-beam Computed Tomography Guided Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction,we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| online adaptive radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Online Adaptive Radiotherapy
- description
- Patients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.
- interventionNames
- Radiation: online adaptive radiotherapy
Primary outcomes (2)
- measure
- The dose coverage of target volume as assessed by planing tumor volume V100%
- timeFrame
- Through study completion, total an average of six month
- description
- 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.
- measure
- A minimum PTV margin could encompass CTV
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDde Jong R, Visser J, van Wieringen N, Wiersma J, Geijsen D, Bel A. Feasibility of Conebeam CT-based online adaptive radiotherapy for neoadjuvant treatment of rectal cancer. Radiat Oncol. 2021 Jul 23;16(1):136. doi: 10.1186/s13014-021-01866-7. PMID 34301300
- BACKGROUNDSchiff JP, Stowe HB, Price A, Laugeman E, Hatscher C, Hugo GD, Badiyan SN, Kim H, Robinson CG, Henke LE. In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. Int J Radiat Oncol Biol Phys. 2022 Dec 1;114(5):1022-1031. doi: 10.1016/j.ijrobp.2022.06.078. Epub 2022 Jun 26. PMID 35768023