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

• Conditions: Locally Advanced Cervical Cancer; Uterine Cervical Neoplasms

• Registration Number: NCT03225443
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Last Update Submitted: 2017-07-19
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Study Start: 2017-09-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
2. The pathological staging: IB2，IIA2

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Exclusion Criteria

Underwent surgery or radiation and chemotherapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The recurrence rate	3 years after treatment

Secondary Outcome Measures

Name	Time	Method
mortality	3 years after treatment
The transfer rate	3 years after treatment

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, China