NCT04974346RecruitingPhase 3
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
Source: ClinicalTrials.gov · Last updated 25 Jan 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 455 (estimated)
- First submitted
- 4 Jul 2021
- Start date
- 2 Aug 2021
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Zhejiang Cancer Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT04974346
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 455
- From 2 Aug 2021 to the primary completion date, 1 Aug 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has received anti-tumor treatment
- Patients with previous pelvic artery embolization
- Previous radiotherapy for pelvic malignant tumor
Other illness
- Uncontrolled severe infection
- Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
- 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)
- 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
- Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
Other
- The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Active, not recruiting |
| Jinhua Municipal Central Hospital Medical Group Coordinator of this site? Confirm its status | Jinhua | China | Active, not recruiting |
| Lishui People's Hospital Coordinator of this site? Confirm its status | Lishui | China | Active, not recruiting |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Active, not recruiting |
| Taizhou Central Hospiatl Coordinator of this site? Confirm its status | Taizhou | China | Active, not recruiting |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Wanzhou | China | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.