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Active, Not Recruiting

NCT Number: NCT05994300

Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer

External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Neoplasm Adaptive Radiotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Radiation Injuries Radiotherapy; Adverse Effect Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

About this study

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age 18 years to 70 years

FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers

FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain

Histology: squamous

Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin

Brachytherapy candidate

Functional State Eastern Cooperative Oncology Group (ECOG)0-2

Exclusion criteria

Patients who had chemotherapeutic, surgical and/or radiotherapy treatment

FIGO stage IIIA, IIIB, IIIC2, IVA or IVB

FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes

Previous pelvic or abdominal radiotherapy

Patient unable to undergo MR scan

ECOG performance status greater than 2

Not a cisplatin candidate

Other factors that contraindicate experimental therapy

Treatment and study plan

Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy

Radiation

Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy

Drug: Concurrent Chemotherapy

Weekly cisplatin 40 mg/m2

Primary 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.

Secondary outcomes

  1. 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.

  2. Response evaluation evaluated with RECIST 1.1

    Time frame: One month after treatment

    Evaluated with RECIST 1.1

  3. Disease-free survival

    Time frame: 3 years

    Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.

  4. Overall survival

    Time frame: 3 years

    Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.

  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.

  6. Quality of life (QoL)

    Time frame: 3 years

    QoL will evaluated by the EORTC QLQ-C-30 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."

  7. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2023
Registry last updated
Jun 8, 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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