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

Who is this study for? Patients with locally advanced cervical cancer
What treatments are being studied? Paraaortic prophylactic irradiation+Pelvic definitive concurrent chemoradiation
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 ⅠB2 - ⅣA 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

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Jinhua Municipal Central Hospital Medical Group
ACTIVE_NOT_RECRUITING
Jinhua
Lishui People's Hospital
ACTIVE_NOT_RECRUITING
Lishui
Ningbo First Hospital
ACTIVE_NOT_RECRUITING
Ningbo
Taizhou Central Hospiatl
ACTIVE_NOT_RECRUITING
Taizhou
Chongqing University Three Gorges Hospital
ACTIVE_NOT_RECRUITING
Wanzhou
Contact Information
Primary
Xiang Zhang
zhangxiang@zjcc.org.cn
0086-571-88122148
Time Frame
Start Date: 2021-08-02
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 455
Treatments
Experimental: study arm
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.
Active_comparator: control arm
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.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital

This content was sourced from clinicaltrials.gov