Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

NCT05682950 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: pumch-ART
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasm; Endometrial Neoplasms

Keywords

Uterine Cervical Neoplasm; Endometrial Neoplasms; Online Adaptive Radiotherapy; Adjuvant Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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, total an average of six month

• A minimum PTV margin could encompass CTV

  Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV.

  Through study completion, toral an average of six month

Secondary Outcomes (6)

• Safety for treatment as assessed by organs at risk doses

  Through study completion, total an average of six month

• Number of participants with acute toxicity as assessed by CTCAE 5.0

  From the start of treatment to 3 months after treatment

• Adaptive time data

  Through study completion, total an average of six month

• Target contouring accuracy

  Through study completion, total an average of six month

• Organs at risk contouring accuracy

  Through study completion, total an average of six month

Study Arms (1)

Online Adaptive Radiotherapy

EXPERIMENTAL

Patients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.

Radiation: online adaptive radiotherapy

Interventions

online adaptive radiotherapy RADIATION

CTV covers pelvis.

Online Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
• 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).
• Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
• Karnofsky score ≥ 70.
• Subjects aged ≥ 18 years and ≤ 70 years.
• No evidence of para-aortic metastatic lymph nodes.
• No contraindications to CT scanning.
• Subjects must be able to cooperate in completing the entire study.
• Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
• Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

You may not qualify if:

• Subjects who have received prior pelvic radiotherapy.
• Subjects with other primary malignancies.
• Subjects with contraindications to radiotherapy, as determined by the investigators.
• 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.
• Active infection with fever.
• Active inflammatory bowel disease.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related 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.

  PMID: 34301300 BACKGROUND

• 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.

  PMID: 35768023 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fuquan Zhang, M.D.

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 12, 2023
• Study Start: September 12, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)