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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Cervical Cancer

Treatments: Drug: chemotherapy group; Radiation: combination group

Study type: Interventional

Funder types: Other

Identifiers

NCT03243825

LC2012B38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

chemo/brachytherapy

Experimental group

Description:

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

Treatment:

Radiation: combination group

chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: chemotherapy group