Uterine Cervical Neoplasms Clinical Trial
Official title:
Shanghai First Maternity and Infant Hospital
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] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai First Maternity and Infant Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai First Maternity and Infant Hospital | RenJi Hospital, Shanghai Proton and Heavy Ion Center |
China,
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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