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NCT03243825 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03243825
Other study ID # LC2012B38
Secondary ID
Status Completed
Phase N/A
First received July 27, 2014
Last updated August 8, 2017
Start date November 2012
Est. completion date July 2015

Study information
Verified date August 2017
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• combination group
chemotherapy (paclitaxel/cisplatinum) and brachytherapy
Drug:
• chemotherapy group
chemotherapy: (paclitaxel/cisplatinum)

Locations
Country Name City State
China Cancer Hospital, Chinese Acadamy of Medical Sceinces Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of post-operative chemo-radiotherapy 2 months
Secondary 3-year disease-free survival 3 years
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