Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study arm | Experimental | External beam radiotherapy: Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least. |
|
| control arm | Active Comparator | External beam radiotherapy: Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation | Radiation | The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate | the percentage of participants in the group whose disease is likely to remain stable | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | the percentage of participants in the group who survives | 3-year |
| Para-aortic recurrence rate | the percentage of participants involved by recurrence in the area of para-aortic lymph node |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Zhang | Contact | 0086-571-88122148 | zhangxiang@zjcc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pelvic definitive concurrent chemoradiation | Radiation | Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy. |
|
| 3-year |
| Distant recurrence rate | the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area | 3-years |
| Side effects | side effects associated with treatment | 3-year |
| Quality of life (QOL) assessed by EORTC QLQ-C30 v3 | an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-C30 v3 ) | 1-month and 6-month |
| Quality of life (QOL) assessed by EORTC QLQ-CX24 | an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-CX24) | 1-month and 6-month |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Active, not recruiting | Hangzhou | China |
| Jinhua Municipal Central Hospital Medical Group | Active, not recruiting | Jinhua | China |
| Lishui People's Hospital | Active, not recruiting | Lishui | China |
| Ningbo First Hospital | Active, not recruiting | Ningbo | China |
| Taizhou Central Hospiatl | Active, not recruiting | Taizhou | China |
| Chongqing University Three Gorges Hospital | Active, not recruiting | Wanzhou | China |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided