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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03243825

Enrollment

120

Registered

2017-08-09

Start date

2012-11-30

Completion date

2015-07-31

Last updated

2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

neoadjuvant chemotherapy, brachytherapy, radiotherapy

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.

Interventions

RADIATIONcombination group

chemotherapy (paclitaxel/cisplatinum) and brachytherapy

DRUGchemotherapy group

chemotherapy: (paclitaxel/cisplatinum)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
proportion of post-operative chemo-radiotherapy	2 months

Secondary

Measure	Time frame
3-year disease-free survival	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026