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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Radiation: combination group; Drug: chemotherapy group

• Registration Number: NCT03243825
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-07-27
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemo/brachytherapy	combination group	Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.
chemotherapy	chemotherapy group	Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.

Primary Outcome Measures

Name	Time	Method
proportion of post-operative chemo-radiotherapy	2 months

Secondary Outcome Measures

Name	Time	Method
3-year disease-free survival	3 years

Trial Locations

Locations (1)

Cancer Hospital, Chinese Acadamy of Medical Sceinces; 🇨🇳 Beijing, China