This is an investigator-initiated, prospective, national multi-center, phase III, randomized, open-label, non-inferiority clinical study. The hypothesis is that using online adaptive radiotherapy technology for moderately fractionated radiotherapy in post-operative patients with cervical/endometrial cancer may reduce radiotherapy-related toxicity and improve quality of life while ensuring target coverage. The objective is to evaluate treatment-related toxicity and efficacy of moderately fractionated online adaptive radiotherapy compared to conventionally fractionated intensity-modulated radiotherapy in post-operative cervical and endometrial cancer patients, aiming to provide a more precise, convenient, and cost-effective treatment option for patients.
Randomization: Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology. Control Group: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology. Stratification Factors for Randomization:Participating study center; Disease type (Cervical cancer / Endometrial cancer); Receipt of concurrent chemotherapy Study Objectives: Primary Endpoint: Acute adverse reactions/toxicity Secondary Endpoints: Late adverse reactions/toxicity, 3-year local control rate, 3-year distant metastasis rate, 3-year progression-free survival (PFS), 3-year overall survival (OS), 3-year disease-free survival (DFS), quality of life, cost-effectiveness analysis related to treatment. Study Population: Planned Sample Size: 228 participants Inclusion Criteria: 1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment. 2. Age ≥18 years and ≤75 years. 3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour. 4. Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy). 5. For participants with cervical cancer, the following criteria must be met: (1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma. (2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion. Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion. 6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1. Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type). 7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy. 8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles. 9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned. Study Duration: September 2025 to September 2030 Participant Involvement Period: Follow-up for over 3 years after radiotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Treatment will be delivered using an online adaptive radiotherapy device. A moderately fractionated regimen will be employed, with a prescribed dose of 40.05 Gy in 15 fractions, administered once daily, five times per week.
Intensity-modulated radiotherapy techniques will be used, including FF-IMRT, VMAT, or TOMO. A conventionally fractionated regimen will be employed, with a prescribed dose of 45 Gy in 25 fractions, administered once daily, five times per week.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of Acute Toxicity
Toxicities occurring within 90 days (inclusive) from the start of radiotherapy are defined as acute toxicities. Acute toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Within 90 days (inclusive) from the start of radiotherapy
Incidence of Late Toxicity
Toxicities occurring more than 90 days after the start of radiotherapy are defined as late toxicities. Late toxicities will be evaluated using the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Time frame: From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.
3 years Local Recurrence Rate
The proportion of subjects who do not experience tumor recurrence or progression within the radiation field within 3 years after the end of radiotherapy.
Time frame: From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.
3 years Distant Metastasis Rate
The proportion of subjects who develop distant metastasis within 3 years after the start of radiotherapy.
Time frame: From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.
3 years Progression-Free Survival
The time interval from the start of radiotherapy to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause within 3 years after the start of radiotherapy.
Time frame: From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.
3 years Overall Survival
The time interval from the start of radiotherapy to death from any cause within 3 years after the start of radiotherapy.
Time frame: From the start of radiotherapy until death from any cause, assessed up to 3 years.
3 years Disease-Free Survival
The time interval from the start of radiotherapy to the first occurrence of local or regional recurrence, distant metastasis, or death from any cause within 3 years after the start of radiotherapy.
Time frame: From the start of radiotherapy until the first local/regional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.
Quality of Life
Quality of life will be assessed using the QLQ-C30 questionnaire, in combination with the disease-specific module (QLQ-CX24 for cervical cancer; QLQ-EN24 for endometrial cancer).
Time frame: Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.
Treatment-Related Cost-Effectiveness Analysis
The cost assessment should cover both medical costs and non-medical costs.
Time frame: From the start of radiotherapy until death from any cause, assessed up to 3 years.
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