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NCT Number: NCT06641635

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.

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Key information

Conditions

Cervical Cancer Adaptive Radiotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, China

Location status: Recruiting

Location contact

Junfang Yan, MD

CONTACT

[email protected]

01069155484

About this study

This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.The purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (NCT05994300).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment
  • Age ≥18 and ≤75 years
  • FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)
  • Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  • Concurrent weekly cisplatin therapy ± immunotherapy
  • Able to undergo brachytherapy
  • ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.

Exclusion criteria

  • Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization
  • FIGO stages IA, IIIC2, IVA, or IVB
  • FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis
  • History of prior abdominal or pelvic radiotherapy
  • Pregnant or breastfeeding women
  • Patients with active infections or fever
  • Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.

Treatment and study plan

Moderated hypofractionated online adaptive radiotherapy

Combination Product

Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy

Experimental group: 43.35Gy/17F external beam radiotherapy with oART + HDR-Brachytherapy

Drug: Concurrent Chemotherapy or immunotherapy

Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

Conventional radiotherapy

Combination Product

Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy

Contral group: 45Gy/25F EBRT + HDR-Brachytherapy

Drug: Concurrent Chemotherapy or immunotherapy

Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

Primary outcomes

  1. Progression Free Survival

    Time frame: 3 years

    Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.

Secondary outcomes

  1. Acute toxicity

    Time frame: 3 months

    This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.

  2. Late toxicity

    Time frame: 3 years

    Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.

  3. Overall survival

    Time frame: 3 years

    Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.

  4. Quality of life (QoL)

    Time frame: 3 years

    QoL will evaluated by the EORTC QLQ-C30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."

  5. Quality of Life (QoL)

    Time frame: 3 years

    QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively.

    The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).

  6. Locoregional progression-free survival

    Time frame: 3 years

    Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first.

  7. Tumor response evaluation Complete remission rate

    Time frame: 3 months

    Evaluated with RECIST 1.1

  8. Metastasis-free survival

    Time frame: 3 years

    Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first.

  9. Cervical cancer-specific survival

    Time frame: 3 years

    Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first.

  10. Treatment expense

    Time frame: 3 months

    The treatment-related costs incurred during the course of treatment.

Other outcomes

  1. Assessment of tumor regression throughout EBRT

    Time frame: 3 months

    To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans.

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Zeng, MD.

CONTACT

[email protected]

86-10-6512-4875

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Peking University Cancer Hospital & Institute
  • Ruijin Hospital
  • Shandong Cancer Hospital and Institute

Registry information

Official study title

A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Oct 15, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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