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

This study is not yet open for participant recruitment.
Verified July 2017 by Shanghai First Maternity and Infant Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03225443
First Posted: July 21, 2017
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
RenJi Hospital
Shanghai Proton and Heavy Ion Center
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital
  Purpose

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.


Condition
Uterine Cervical Neoplasms Locally Advanced Cervical Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Shanghai First Maternity and Infant Hospital

Resource links provided by NLM:


Further study details as provided by Shanghai First Maternity and Infant Hospital:

Primary Outcome Measures:
  • The recurrence rate [ Time Frame: 3 years after treatment ]

Secondary Outcome Measures:
  • The transfer rate [ Time Frame: 3 years after treatment ]
  • mortality [ Time Frame: 3 years after treatment ]

Estimated Enrollment: 50
Anticipated Study Start Date: September 30, 2017
Estimated Study Completion Date: September 30, 2020
Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
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.
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225443


Locations
China
Shanghai First Maternity and Infant Hospital Not yet recruiting
Shanghai, China
Contact: Xioaqing Guo, PhD    18117203488    xiaoqingguo333@163.com   
Contact: Na Liu, PhD    15601745699    1517693296@qq.com   
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital
RenJi Hospital
Shanghai Proton and Heavy Ion Center
  More Information

Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT03225443     History of Changes
Other Study ID Numbers: Xiaoqing Guo
First Submitted: July 19, 2017
First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai First Maternity and Infant Hospital:
Locally advanced cervical cancer
Particle radiotherapy
Neoadjuvant Chemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female