Recruiting

Surgery alone versus surgery plus radiation for early cervical cancer

Plain-English translation of NCT04989647 on ClinicalTrials.gov ↗ · Source last updated September 2023 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This international trial is comparing two treatment approaches for women with early-stage cervical cancer that has certain risk factors. All participants will have surgery to remove the cancer and nearby lymph nodes. Then, half of the women will receive no additional treatment, while the other half will receive radiation therapy (sometimes combined with chemotherapy) after surgery. The trial wants to find out which approach works better and is safer for patients.

For over 20 years, doctors have been uncertain whether women with this type of intermediate-risk cervical cancer actually benefit from radiation after surgery. Recent studies suggest that surgery alone may work well for some patients, so this large, international trial is designed to give clear answers about who really needs the additional treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with invasive cervical cancer that is early-stage (FIGO stage IB1 to IIA)
your cancer is either squamous cell type or HPV-related adenocarcinoma
your tumor has one or more risk factors: size of 4 cm or larger, or size between 2-4 cm with invasion into blood vessels, very close margins, or deep invasion into the cervix
imaging and lymph node testing show no spread to pelvic lymph nodes or distant organs before surgery
you are in good enough health to undergo surgery and possibly radiation therapy (ECOG performance status 0-1)

You likely don't qualify if…

you have a rare type of cervical cancer (such as mucinous, clear cell, or non-HPV-related adenocarcinoma)
you have had radiation therapy to the pelvic area before
you have a history of cancer elsewhere in your body within the past 3 years
you received chemotherapy before surgery
you are pregnant or unable to comply with follow-up care

What participation looks like

You will first have the standard surgical procedure (radical hysterectomy and lymph node removal). Before surgery begins, you will be enrolled in the trial. After surgery, once the pathology results come back, you will be randomly assigned to either receive no further treatment or to receive adjuvant (follow-up) radiation therapy, with or without chemotherapy. The trial includes quality checks to ensure both the surgery and any follow-up treatment are done properly. You will be followed over time to see how well each approach works.

AI-generated summary from trial data · Jun 16, 2026 · Not medical advice

Trial locations(1 site)

Czechia

General University Hospital in Prague, Prague