Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

NCT06641635 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: SWIFT-1
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer; Adaptive Radiotherapy

Keywords

Cervical Cancer; Moderated Hypofractionated Radiotherapy; Adaptive Radiotherapy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  3 years

Secondary Outcomes (10)

• Acute toxicity

  3 months

• Late toxicity

  3 years

• Overall survival

  3 years

• Quality of life (QoL)

  3 years

• Quality of Life (QoL)

  3 years

Other Outcomes (1)

• Assessment of tumor regression throughout EBRT

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental

Combination Product: Moderated hypofractionated online adaptive radiotherapy

Control group

ACTIVE COMPARATOR

Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care

Combination Product: Conventional radiotherapy

Interventions

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

Experimental group

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Zeng Z, Chen Y, Qiu J, Yang B, Wang Z, Meng X, Sun Y, Yan J, Hu K, Zhang F. Moderately hypofractionated online adaptive radiotherapy (SWIFT-1) in cervical cancer patients: study protocol for a multi-centered, open-label, two-arm, phase III, randomized controlled study. Radiat Oncol. 2025 Jul 16;20(1):112. doi: 10.1186/s13014-025-02688-7.

  PMID: 40671096 DERIVED

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

Central Study Contacts

Zheng Zeng, MD.

CONTACT

86-10-6512-4875; zengzheng1206@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2029
• Last Updated: March 18, 2025

Record last verified: 2024-10

Locations

CN (1)