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

NCT03225443 | Unknown

• 1 other identifier: Xiaoqing Guo
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms; Locally Advanced Cervical Cancer

Keywords

Locally advanced cervical cancer; Particle radiotherapy; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The recurrence rate

  3 years after treatment

Secondary Outcomes (2)

• The transfer rate

  3 years after treatment

• mortality

  3 years after treatment

Study Arms (2)

Particle Radiotherapy

The patients will receive particle radiotherapy before operation,and then radical hysterectomy, removal of pelvic lymph nodes and abdominal aorta lymph nodes would be conducted. Besides ovary reservation would be made according to the individual situation. Concurrent radiation and chemotherapy would be performed according to the clinical situation.

Neoadjuvant Chemotherapy

The patients will receive NACT before operation,and then radical hysterectomy, removal of pelvic lymph nodes and abdominal aorta lymph nodes would be conducted. Besides ovary reservation would be made according to the individual situation. Concurrent radiation and chemotherapy would be performed according to the clinical situation.

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
• The pathological staging: IB2，IIA2

You may not qualify if:

• Underwent surgery or radiation and chemotherapy

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead
• RenJi Hospital: collaborator
• Shanghai Proton and Heavy Ion Center: collaborator

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: September 30, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

CN (1)