Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Phase 1

Active, not recruiting

• Conditions: Endometrial Neoplasms; Uterine Cervical Neoplasm
• Interventions: Radiation: Online adaptive radiotherapy

• Registration Number: NCT05869123
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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).

Study Timeline

• Study Start: 2022-10-20
• Primary Completion: 2023-03-03
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online Adaptive Radiotherapy	Online adaptive radiotherapy	Patients receive online adaptive radiotherapy with 5mm PTV margin. The CTV-N covered pelvic lymph nodes (common, internal and external iliac, obturator, and presacral) and CTV-V covered proximal vagina and any paravaginal or retracted parametrial tissue. A dose of 45 or 50.4Gy is delivered to CTV with online adaptive radiotherapy.

Primary Outcome Measures

Name	Time	Method
Physician-reported acute toxicity	From the start of treatment to 3 months after treatment	Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0

Secondary Outcome Measures

Name	Time	Method
The dose coverage of target volume as assessed by planing tumor volume V100%	Through study completion, an average of five 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.
Target automatically contouring accuracy	Through study completion, an average of five 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.
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme	2-year	Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Organs at risk contouring accuracy	Through study completion, an average of five 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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China