Endometrial Neoplasms, Uterine Cervical Neoplasm
Conditions
Keywords
Uterine Cervical Neoplasm, Endometrial Neoplasms, Online Adaptive Radiotherapy, Adjuvant Radiotherapy
Brief summary
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.
Detailed description
This is a prospective phase II clinical trial with an anticipated total of more than 380 radiotherapy fractions of 15 patients to evaluate optimal margin of iterative cone-beam computed tomography（iCBCT） guided online adaptive radiotherapy （oART） for postoperative treatment of endometrial and cervical cancer. Postoperative endometrial and cervical cancer patients with following characteristics are included in the present study:（a）underwent radical surgery （b）no residual tumor at the resection margin by postoperative pathology（c）pathological findings indicate risk factors but no metastasis (d) adjuvant radiotherapy are prescribe (e)without evidence of para-aortic metastatic lymph nodes. Five patients （almost 125 fractions）treated with oART have the target volume contoured on pre-treatment iCBCTs and end-treatment iCBCTs. Anterior-posterior, lateral, and superior-inferior shifts were calculated and the average shift in all directions was calculated. A clinical target volume (CTV) to planing tumor volume (PTV) expansion is determined and verifies on a validation cohort of 10 patients (almost 250 fractions) treated with oART. Record acute toxicity from the start of treatment to 3 months after treatment.
Interventions
RADIATIONonline adaptive radiotherapy
CTV covers pelvis.
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 |
|---|---|---|
| The dose coverage of target volume as assessed by planing tumor volume V100% | Through study completion, total an average of six 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. |
| A minimum PTV margin could encompass CTV | Through study completion, toral an average of six month | Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety for treatment as assessed by organs at risk doses | Through study completion, total an average of six month | Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc |
| Number of participants with acute toxicity as assessed by CTCAE 5.0 | From the start of treatment to 3 months after treatment | Evaluated with CTCAE 5.0 |
| Adaptive time data | Through study completion, total an average of six month | For each treatment in each fraction, adaptive time was recorded from first cone beam computed tomography (CBCT) to the selection of the preferred plan for the treatment. |
| Target contouring accuracy | Through study completion, total an average of six 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, total an average of six 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. |
| Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme | total an average of 2-year | Evaluated every three months with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme |
Countries
China
Contacts
STUDY_CHAIRFuquan Zhang, M.D.
Peking Union Medical College Hospital
Outcome results
None listed