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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03225443
Other study ID # Xiaoqing Guo
Secondary ID
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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