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Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

combination group

chemotherapy group

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring neoadjuvant chemotherapy, brachytherapy, radiotherapy

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Histology confirmed cervical cancer
Clinical stage Ib2 or IIa2 (FIGO 2009)

Exclusion Criteria:

Patients who not suitable for surgery
Personal history of pelvic radiotherapy

Sites / Locations

Cancer Hospital, Chinese Acadamy of Medical Sceinces

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chemo/brachytherapy

chemotherapy

Arm Description

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.

Outcomes

Primary Outcome Measures

proportion of post-operative chemo-radiotherapy

Secondary Outcome Measures

3-year disease-free survival

Full Information

NCT ID

NCT03243825

First Posted

July 27, 2014

Last Updated

August 8, 2017

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03243825

Brief Title

Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

Official Title

Comparative Study of Neoadjuvant Chemo/Brachytherapy and Chemotherapy Alone Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent chemo-radiotherapy is necessary if the patients have high-risk factors, including positive surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.

Detailed Description

In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and pelvic+/- para-aortic lymph node dissection. According to the surgical findings, post-operative chemo-radiotherapy will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

neoadjuvant chemotherapy, brachytherapy, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemo/brachytherapy

Arm Type

Experimental

Arm Description

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.

Intervention Type

Radiation

Intervention Name(s)

combination group

Intervention Description

chemotherapy (paclitaxel/cisplatinum) and brachytherapy

Intervention Type

Drug

Intervention Name(s)

chemotherapy group

Intervention Description

chemotherapy: (paclitaxel/cisplatinum)

Primary Outcome Measure Information:

Title

proportion of post-operative chemo-radiotherapy

Time Frame

2 months

Secondary Outcome Measure Information:

Title

3-year disease-free survival

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histology confirmed cervical cancer Clinical stage Ib2 or IIa2 (FIGO 2009) Exclusion Criteria: Patients who not suitable for surgery Personal history of pelvic radiotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ning Li, MD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital, Chinese Acadamy of Medical Sceinces

City

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

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