Cervical cancer
Conditions
Interventions
Experimental group:Medium-fractionated radiotherapy is applied as adjuvant therapy for early squamous cell carcinoma with only moderate-risk factors after radical surgery for cervical cancer
Control group:Conventional fractionated radiotherapy is applied as adjuvant therapy for early squamous cell carcinoma with only intermediate-risk factors after radical surgery for cervical cancer
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Cervical cancer patients (who have undergone radical surgery for cervical cancer within 8 weeks, with FIGO 2018 IA1-IIA2, and only have >=2 intermediate-risk factors), who have not previously received any definitive radiotherapy or systemic treatment for cervical cancer, and are assessed by a radiation therapist as being eligible for radiation therapy; 2) Previously histologically confirmed squamous cell carcinoma of the cervix; 3) The researchers assessed that the patient was suitable for radiotherapy; 4) ECOG score 0-1; 5) Aged 18-70; 6) No severe allergic history; 7) Hemoglobin >=100 g/L, white blood cell (WBC) count >=3.5*10^9/L, neutrophil count >=1.5*10^9, platelet count >=100*10^9/L; CR1.5 is the upper limit of normal, TB2.5 is the upper limit of normal, AST and ALT2.5 are the upper limits of normal, AKP2.5 is the upper limit of normal; 8) Good renal function; 9) Able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Have undergone chemotherapy, radiotherapy, immunotherapy, or other anti-tumor treatments; have contraindications to platinum-based chemotherapy; 2) Histologically diagnosed with adenocarcinoma, adenosquamous carcinoma, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, carcinosarcoma, or other pathological types; 3) Postoperative pathology confirms tumor infiltration depth to be full-thickness or deeper; Postoperative pathology confirmed the presence of high-risk factors; 4) lymph node metastasis and distant metastasis; 5) bilateral hydronephrosis, unable to place ureteral stents or perform nephrostomy; 6) other malignancies; 7) pregnant or lactating patients; 8) previous thyroid dysfunction, and despite medication, thyroid function cannot be maintained within the normal range; 9) diagnosed with immune deficiency or receiving chronic systemic steroid treatment (daily dose exceeding 10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before enrollment; 10) active autoimmune disease requiring systemic treatment within the past 2 years; 11) history of steroid-requiring (non-infectious) pneumonia or current pneumonia; 12) active infection requiring systemic treatment; 13) known history of human immunodeficiency virus (HIV) infection; 14) known history of hepatitis B or known active hepatitis C virus infection; 15) known history of active tuberculosis (TB; Mycobacterium tuberculosis); 16) uncontrolled comorbidities, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, uncontrolled hypertension, uncontrolled diabetes, uncontrolled arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal disease accompanied by diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the subject's ability to provide written informed consent; 17) major surgery within 14 days before enrollment and not yet recovered; 18) currently participating in or within 28 days before enrollment in another clinical trial; 19) exposure to immune-mediated therapy for any indication before the study, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies or therapeutic cancer vaccines; 20) any concurrent chemotherapy, study drug, biologic, or hormonal therapy for tumor treatment. Hormonal 1. Have undergone chemotherapy, radiotherapy, immunotherapy, or other anti-tumor treatments; have contraindications to platinum-based chemotherapy; 2. Histologically diagnosed with adenocarcinoma, adenosquamous carcinoma, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, carcinosarcoma, or other pathological types; 3. Postoperative pathology confirms tumor infiltration depth to be full-thickness or deeper; Postoperative pathology confirmed the presence of high-risk factors; 4. Lymph node metastasis and distant metastasis; 5. Bilateral hydronephrosis, unable to place ureteral stents or perform nephrostomy; 6. Other malignancies; 7. Pregnant or lactating patients; 8. Previous thyroid dysfunction, and despite medication, thyroid function cannot be maintained within the normal range; 9. Diagnosed with immune deficiency or receiving chronic systemic steroid treatment (daily dose exceeding 10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before enrol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactJun Zhu
Fudan University Shanghai Cancer Center
Outcome results
None listed