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Trial Title:
Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
NCT ID:
NCT05869123
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 1/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:
PTV with 5 margins covers CTV
Arm group label:
Online Adaptive Radiotherapy
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).
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:
October 20, 2022
Completion date:
March 3, 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/NCT05869123
