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

Shanghai First Maternity and Infant Hospital

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03225443

Enrollment

Registered

2017-07-21

Start date

2017-09-30

Completion date

2020-09-30

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Cervical Cancer, Uterine Cervical Neoplasms

Keywords

Locally advanced cervical cancer, Particle radiotherapy, Neoadjuvant Chemotherapy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Inclusion criteria

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

Exclusion criteria

Underwent surgery or radiation and chemotherapy

Design outcomes

Primary

Measure	Time frame
The recurrence rate	3 years after treatment

Secondary

Measure	Time frame
The transfer rate	3 years after treatment
mortality	3 years after treatment

Countries

China

Outcome results