Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

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.

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.

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.

Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation

Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Pelvic definitive concurrent chemoradiation

Xiang Zhang

Jianhong Chen

Yeqiang Tu

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.

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study

the percentage of participants in the group whose disease is likely to remain stable

the percentage of participants in the group who survives

the percentage of participants involved by recurrence in the area of para-aortic lymph node

the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area

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 )

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital

Spots Global Cancer Trial Database for paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation