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Trial Title:
Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
NCT ID:
NCT05682950
Condition:
Uterine Cervical Neoplasm
Endometrial Neoplasms
Conditions: Official terms:
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Conditions: Keywords:
Uterine Cervical Neoplasm
Endometrial Neoplasms
Online Adaptive Radiotherapy
Adjuvant Radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
online adaptive radiotherapy
Description:
CTV covers pelvis.
Arm group label:
Online Adaptive Radiotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
September 12, 2022
Completion date:
February 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682950
