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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05869123
Other study ID # pumch-ART-1
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 20, 2022
Est. completion date March 3, 2025

Study information

Verified date June 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date March 3, 2025
Est. primary completion date March 3, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Radiation:
Online adaptive radiotherapy
PTV with 5 margins covers CTV

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

de 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. — View Citation

Schiff 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physician-reported acute toxicity Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0 From the start of treatment to 3 months after treatment
Secondary Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme 2-year
Secondary The dose coverage of target volume as assessed by planing tumor volume V100% 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. Through study completion, an average of five month
Secondary Target automatically contouring accuracy 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. Through study completion, an average of five month
Secondary Organs at risk contouring accuracy 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. Through study completion, an average of five month
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