Postoperative cervical or uterine corpus cancer
Conditions
Interventions
Experimental Group:Moderately Hypofractionated Adaptive Postoperative Radiotherapy
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects are fully voluntary and competent, and must sign the study informed consent form within 30 days before enrollment. 2.Aged >= 18 years and = 4 cm, regardless of stromal invasion depth and LVSI status; for adenocarcinoma: tumor size >= 2 cm, or positive LVSI, regardless of stromal invasion depth). 6.Subjects with uterine corpus cancer must meet the following enrollment criteria: (1) For endometrial endometrioid adenocarcinoma: G3 with superficial myometrial invasion, accompanied by extensive LVSI or age >= 70 years; G2 with deep myometrial invasion, accompanied by extensive LVSI or age >= 60 years; G3 with deep myometrial invasion; FIGO 2009 stage II-III C1; (2) For non-endometrioid adenocarcinoma: FIGO 2009 stage I-III C1 serous carcinoma, clear cell carcinoma, or mixed carcinoma. 7.Subjects with high-risk factors may receive vaginal brachytherapy boost after the completion of external beam radiotherapy; 8.High-risk subjects with cervical cancer must receive concurrent sensitizing chemotherapy for >= 4 cycles. 9.Enrolled subjects may receive standard sequential or sandwich adjuvant chemotherapy.
Exclusion criteria
Exclusion criteria: 1.With definite distant metastasis or para-aortic lymph node metastasis; 2.Requiring retroperitoneal extended-field radiotherapy; 3.For subjects whose interval between radiotherapy initiation and surgery exceeds the time limit: if adjuvant chemotherapy is administered, the interval between radiotherapy initiation and surgery exceeds 6 months; if no adjuvant chemotherapy is administered, the interval exceeds 3 months; 4.Previous history of abdominal or pelvic radiotherapy; 5.Previous or concurrent second primary malignant tumor (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and ductal carcinoma in situ of the breast); 6.Subjects with a history of underlying intestinal diseases such as ulcerative colitis and Crohn's disease; 7.For cervical cancer: pathological types are other special types (e.g., adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma); For uterine corpus cancer: pathological types are other special types (e.g., undifferentiated carcinoma, carcinosarcoma); 8.Pregnant or lactating women; 9.With active infection or fever; 10.Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes mellitus, and mental illness that require treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year progress-free survival;3 year overall survival;Chronic Toxicity;3 year disease-free survival;3 year local control;3 year distant metastasis;Treatment-related cost-effectiveness analysis;Quality of life; | — |
Countries
China
Contacts
Public ContactXiaorong Hou
Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed