Status:

RECRUITING

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

Lead Sponsor:

Peking Union Medical College Hospital

Collaborating Sponsors:

Peking University Cancer Hospital & Institute

Shandong Cancer Hospital and Institute

Conditions:

Cervical Cancer

Adaptive Radiotherapy

Eligibility:

FEMALE

18-75 years

Phase:

PHASE3

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 availabil...

Detailed Description

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 thi...

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization
  2. FIGO stages IA, IIIC2, IVA, or IVB
  3. FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis
  4. History of prior abdominal or pelvic radiotherapy
  5. Pregnant or breastfeeding women
  6. Patients with active infections or fever
  7. 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.

Key Trial Info

Start Date :

November 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2029

Estimated Enrollment :

440 Patients enrolled

Trial Details

Trial ID

NCT06641635

Start Date

November 19 2024

End Date

October 31 2029

Last Update

March 18 2025

Active Locations (1)

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Peking Union Medical College Hospital

Beijing, China

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer | DecenTrialz