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

Uterine Cervical Neoplasms Clinical Trial

Official title:

Shanghai First Maternity and Infant Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03225443
• Other study ID #: Xiaoqing Guo
• Status: Not yet recruiting
• Phase: N/A
• First received: July 19, 2017
• Last updated: July 19, 2017
• Start date: September 30, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2017
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma

2. The pathological staging: IB2,IIA2

Exclusion Criteria:

Underwent surgery or radiation and chemotherapy

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital	RenJi Hospital, Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate		3 years after treatment
Secondary	The transfer rate		3 years after treatment
Secondary	mortality		3 years after treatment