Clinical trial NCT03225443: Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy
Official title: Shanghai First Maternity and Infant Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasms
Locally Advanced Cervical Cancer
Keywords: Locally advanced cervical cancer
Particle radiotherapy
Neoadjuvant Chemotherapy
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai Proton and Heavy Ion Center
First posted: 2017-07-21
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from Sep 2017 until Sep 2020 in Shanghai First Maternity and Infant Hospital, Tongji University and Renji Hospital Shanghai Jiaotong University School of Medicine.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Underwent surgery or radiation and chemotherapy

Primary outcomes:
measure: The recurrence rate
timeFrame: 3 years after treatment
Secondary outcomes:
measure: The transfer rate
timeFrame: 3 years after treatment
measure: mortality
timeFrame: 3 years after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
Study officials:
References: