Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer

NCT05994300 | Active Not Recruiting DMC

• 1 other identifier: MHARTCC-Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Neoplasm; Adaptive Radiotherapy; Radiotherapy; Adverse Effect

Keywords

moderately hypofractionated radiotherapy; adaptive radiotherapy; cervical cancer.

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  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.

  3 months

Secondary Outcomes (7)

• Late toxicity

  3 years

• Response evaluation evaluated with RECIST 1.1

  One month after treatment

• Disease-free survival

  3 years

• Overall survival

  3 years

• Quality of life (QoL)

  3 years

Study Arms (1)

Moderately Hypofractionated Adaptive Radiotherapy

EXPERIMENTAL

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

Interventions

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

Moderately Hypofractionated Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Radiation Injuries

Interventions

Brachytherapy

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; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Fuquan Zhang, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 16, 2023
• Study Start: September 19, 2023
• Primary Completion: July 22, 2024
• Study Completion: December 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)