Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

NCT05880485 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: pumch-ART2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Conditions

Uterine Cervical Neoplasm

Keywords

Uterine Cervical Neoplasm; Online Adaptive Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Patient-reported acute toxicity

  Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire

  From the start of treatment to 3 months after treatment

• 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 Outcomes (9)

• Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

  2-year

• The irradiated doses of organs at risk

  Through study completion, an average of eight month

• The dose coverage of target volume as assessed by planing tumor volume V100%

  Through study completion, an average of eight month

• Target volume contouring accuracy

  Through study completion, an average of eight month

• Response evaluation evaluated with RECIST 1.1

  One month after treatment

Study Arms (1)

Online Adaptive Radiotherapy

EXPERIMENTAL

Patients receive online adaptive radiotherapy with 5-10mm PTV margin. The CTV contours of the following areas: gross tumor volume (GTV), cervix (if not already encompassed by the GTV), uterus, parametria, ovaries, vaginal tissue, 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 50.4Gy is delivered to CTV with online adaptive radiotherapy.

Radiation: online adaptive radiotherapy

Interventions

online adaptive radiotherapy RADIATION

PTV with 5-10 margins covers CTV

Online Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 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.
• Age ≥18 years and ≤ 75 years.
• Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
• No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
• No contraindications to CT scanning.
• No evidence of distant metastasis (FIGO stage IVB).
• 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:

• With common iliac MLNs.
• Tumor extended to the lower third of the vagina.
• Tumor spread to mucosa of the bladder or rectum.
• Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
• Prior malignancy.
• History of previous radiotherapy to the abdomen or pelvis.
• Pregnancy or lactation.
• Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
• Active infection with fever.
• Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
• 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.

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

• Yen A, Choi B, Inam E, Yeh A, Lin MH, Park C, Hrycushko B, Nwachukwu C, Albuquerque K. Spare the Bowel, Don't Spoil the Target: Optimal Margin Assessment for Online Cone Beam Adaptive Radiation Therapy (OnC-ART) of the Cervix. Pract Radiat Oncol. 2023 Mar-Apr;13(2):e176-e183. doi: 10.1016/j.prro.2022.10.009. Epub 2022 Nov 7.

  PMID: 36356834 RESULT

MeSH Terms

Conditions

Uterine Cervical 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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 30, 2023
• Study Start: February 2, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)