Clinical trial NCT06641635: Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer
Official title: A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Adaptive Radiotherapy
Keywords: Cervical Cancer
Moderated Hypofractionated Radiotherapy
Adaptive Radiotherapy
Randomized controlled trial
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Shandong Cancer Hospital and Institute
name: Ruijin Hospital
First posted: 2024-10-15
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Acute toxicity
timeFrame: 3 months
measure: Late toxicity
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Quality of life (QoL)
timeFrame: 3 years
measure: Quality of Life (QoL)
timeFrame: 3 years
measure: Locoregional progression-free survival
timeFrame: 3 years
measure: Tumor response evaluation Complete remission rate
timeFrame: 3 months
measure: Metastasis-free survival
timeFrame: 3 years
measure: Cervical cancer-specific survival
timeFrame: 3 years
measure: Treatment expense
timeFrame: 3 months
Other outcomes:
measure: Assessment of tumor regression throughout EBRT
timeFrame: 3 months
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: