Clinical Study in Post-operation Treatment of Cervical Cancer

Health Science Center of Xi'an Jiaotong University

Status: Unknown

Conditions: Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01418859

GCR-01

Details and patient eligibility

About

The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Full description

Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Enrollment: 183 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
2. squamous carcinoma;
3. age<70;
4. Gynecologic Oncology Group (GOG):0-2.

Exclusion criteria

1. negative nodes,surgical margin,and/or parametrium;
2. No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.

Trial design

183 participants in 3 patient groups

radiation therapy only

Description:

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive radiation therapy only. radiation therapy regimen: 3D-CRT pelvic radiation, 95%CTV DT 45Gy/25f. Radiation field include tumor bed and regional lymph nodes area. Upper border: branching of abdominal aorta. The radiation fields go down along the iliac vessels (including regions of 7mm out of the iliac vessels) and include the tumor bed region. Lower border: the inferior margin of obturator foramen.

concurrent chemoradiotherapy

Description:

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy. radiation therapy regimen is the same with radiation therapy only group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy.

concurrent and additional chemotherapy

Description:

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy, and additional chemotherapy after concurrent treatment. radiation therapy regimen is the same with radiation therapy group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy. Additional chemotherapy regimen is the same with concurrent chemotherapy, and will be carry out in the 4th and 8th week after radiation therapy.