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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

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

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer (NCT04974346) is a Phase 3 interventional studying Cervical Cancer, sponsored by Zhejiang Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Cervical Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 455 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - The patients voluntarily participated in the study and signed the willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 weakened immune system, including HIV positive or other acquired congenital weakened immune system 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 willing to sign a consent form ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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 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

Treatments Being Tested

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.

RADIATION

Pelvic definitive concurrent chemoradiation

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

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 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, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04974346), the sponsor (Zhejiang Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04974346 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04974346?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04974346?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04974346. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04974346. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.