Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Cervical Cancer Clinical Trial

— PAILACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974346
• Other study ID #: CARTOnG 2101
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2, 2021
• Est. completion date: August 1, 2030

Study information

• Verified date: July 2021
• Source: Zhejiang Cancer Hospital
• Contact: Xiang Zhang
• Phone: 0086-571-88122148
• Email: zhangxiang[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 455
• Est. completion date: August 1, 2030
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The patients voluntarily participated in the study and signed the informed consent

• 18-75 female

• Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma

• According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ?B2 - ?A with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT

• Cisplatin chemotherapy is acceptable

• Eastern Cooperative Oncology Group(ECOG) score 0-1

• The expected survival was more than 6 months

• Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test

• According to the judgment of the researcher, those who can comply with the trial protocol

Exclusion Criteria:

• Uncontrolled severe infection

• Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years

• The patient has received anti-tumor treatment

• Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure

• History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease

• Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)

• Patients with previous pelvic artery embolization

• Previous radiotherapy for pelvic malignant tumor

• There was a history of severe allergic reaction to platinum containing chemotherapy drugs

• Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis

• The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent

• Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
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.
• Pelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Jinhua Municipal Central Hospital Medical Group	Jinhua
China	Lishui People's Hospital	Lishui
China	Ningbo First Hospital	Ningbo
China	Taizhou Central Hospiatl	Taizhou
China	Chongqing University Three Gorges Hospital	Wanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate	the percentage of participants in the group whose disease is likely to remain stable	3-year
Secondary	Overall survival rate	the percentage of participants in the group who survives	3-year
Secondary	Para-aortic recurrence rate	the percentage of participants involved by recurrence in the area of para-aortic lymph node	3-year
Secondary	Distant recurrence rate	the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area	3-years
Secondary	Side effects	side effects associated with treatment	3-year
Secondary	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
Secondary	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