Trials / Completed
CompletedNCT03243825
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- Female
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | combination group | chemotherapy (paclitaxel/cisplatinum) and brachytherapy |
| DRUG | chemotherapy group | chemotherapy: (paclitaxel/cisplatinum) |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2015-06-01
- Completion
- 2015-07-01
- First posted
- 2017-08-09
- Last updated
- 2017-08-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03243825. Inclusion in this directory is not an endorsement.