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Trial Title:
Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer
NCT ID:
NCT06641635
Condition:
Cervical Cancer
Adaptive Radiotherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical Cancer
Moderated Hypofractionated Radiotherapy
Adaptive Radiotherapy
Randomized controlled trial
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Moderated hypofractionated online adaptive radiotherapy
Description:
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
Arm group label:
Experimental group
Intervention type:
Combination Product
Intervention name:
Conventional radiotherapy
Description:
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
Arm group label:
Control group
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).
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 31, 2024
Completion date:
October 31, 2029
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06641635
