Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Locally advanced cervical cancer (LACC) refers to the clinically cervical visible lesion with a diameter of > 4 cm, which has been considered as a high risk of early cervical cancer for a long time. Because of local bulk lesion of LACC, the risk of radical hysterectomy is pretty high and the radical effect commonly does not meet the satisfactory. Therefore, 1-3 course of neoadjuvant chemotherapy (NACT) were carried out before operation. However, nearly 20% of patients are not sensitive to NACT. Therefore NACT did not bring any benefits to radical surgery even to some extent delayed the treatment. Traditional radiotherapy is also commonly used in the treatment of LACC, however ovarian function would be permanently destroyed especially for young patients, additionally radioactive complications to adjacent organs of cervical such as vagina, bladder and rectal also commonly happened, moreover sexual dysfunction after radiotherapy significantly affect the life quality of young patients. Particle radiotherapy developed recently, has the advantages of short course of treatment and mild side effects, due to its special working mechanism, Bragg effect. So the amount of radiation in the tumor tissue is very extremely high, and in the adjacent tissue is quiet low, therefore the organs at risk were protected by avoiding unnecessary damage. Based on these, we proposed the application of particle radiotherapy in LACC pre-operation, and comprehensively evaluated recent curative effect, complications and long-term follow-up between particle radiotherapy and NACT. Furthermore, the clinical significance and long-term application prospects about particle therapy were objectively assessed.

Official Title
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Shanghai First Maternity and Infant Hospital

Conditions
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Uterine Cervical Neoplasms, Locally Advanced Cervical Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma The pathological staging: IB2，IIA2 Exclusion Criteria: Underwent surgery or radiation and chemotherapy
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Particle Radiotherapy<br>The patients will receive particle radiotherapy before operation,and then radical hysterectomy, removal of pelvic lymph nodes and abdominal aorta lymph nodes would be conducted. Besides ovary reservation would be made according to the individual situation. Concurrent radiation and chemotherapy would be performed according to the clinical situation. | |
| Neoadjuvant Chemotherapy<br>The patients will receive NACT before operation,and then radical hysterectomy, removal of pelvic lymph nodes and abdominal aorta lymph nodes would be conducted. Besides ovary reservation would be made according to the individual situation. Concurrent radiation and chemotherapy would be performed according to the clinical situation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate |  | 3 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The transfer rate |  | 3 years after treatment | 
| mortality |  | 3 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced cervical cancer, Particle radiotherapy, Neoadjuvant Chemotherapy