Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Endometrial Neoplasms Clinical Trial

Official title:

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical With Reduced Margin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05869123
• Other study ID #: pumch-ART-1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasms
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

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