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Taking peoplePhase 3

Surgery Followed by Radiotherapy or Observation for Early-Stage Cervical Cancer

Tests whether radiation after surgery helps adults with early intermediate-risk cervical cancer.

Key facts

Who runs it
The Central and Eastern European Gynecologic Oncology Group
Where
Rome, ItalySee the siteAlso in 6 other countries, 37 sites
Trial code
Registry title
Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
Status
Recruiting
Phase
Phase 3
People taking part
514 people, planned
Started
10 Jun 2022
Expected to end
Dec 2032
Type of study
Interventional, 2 groups
Treatments tested
  • No adjuvant therapy
  • Adjuvant radiotherapy
Record updated
7 September 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 to 85 with early-stage cervical cancer and intermediate risk factors, who are fit for radical surgery followed by radiotherapy.

Age
18 Years to 85 Years
Sex
Women only.
Disease stage
Invasive cervical cancer, FIGO IB1-IIA, squamous cell cancer or HPV-related adenocarcinoma. Tumour-related risk factors must be present, such as a tumour of 4 cm (1.6 in) or more, or a tumour larger than 2 cm (0.8 in) and smaller than 4 cm (1.6 in) with other risk features. No suspicious pelvic lymph nodes or distant spread on imaging.
Earlier treatment
No previous pelvic radiotherapy. No chemotherapy given before surgery. Fit for radical surgery followed by adjuvant radiotherapy.
Biomarker or test result
Negative pregnancy test (if applicable). Negative HIV test (only done in high-risk countries or for patients who moved from those countries within the past 10 years).

Main reasons for not taking part

  • Adenosquamous cancer, unusual adenocarcinoma types not related to HPV, or other rare tumour types
  • Unequivocally positive lymph node on imaging
  • FIGO stage below IB1 or above IIA
  • Previous pelvic cancer, or a second primary cancer outside the pelvis with 3 years or less of complete clinical remission
  • Low likelihood of keeping to the follow-up

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Pathologically confirmed invasive cervical cancer
  • FIGO IB1-IIA
  • Squamous cell cancer or HPV-related adenocarcinoma
  • Presence of tumour-related risk factors as follows:; tumour ≥4 cm OR; tumour>2 cm <4 cm AND lymphovascular space invasion OR; tumour >2 cm <4 cm AND tumour free distance <3 mm OR; tumour >2 cm <4 cm AND deep stromal invasion (>2/3)
  • No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)
  • ECOG performance status 0-1
  • Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy
  • Negative pregnancy test (if applicable)
  • Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)

Who cannot take part

  • Previous pelvic malignancy
  • Previous pelvic radiotherapy
  • Neoadjuvant chemotherapy prior surgical treatment
  • Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)
  • Inconclusive primary site of disease
  • History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
  • Unequivocally positive lymph node by imaging (by radiological subjective assessment)
  • FIGO <IB1 / >IIA
  • Low likelihood of patient compliance to the follow-up

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in Italy

Also in 6 other countries, 37 sites

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting

About the trial

What the trial wants to find out

The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).

The 2 groups in the trial

  • A: Surgery onlyTreatment being tested

    Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\*. No further treatment will be administered. \*PLND can be avoided in patients with tumours \< 4cm

    Treatment: No adjuvant therapy

  • B: Surgery + radiothrerapyTreatment being tested

    Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\*, followed by adjuvant treatment. \*PLND can be avoided in patients with tumours \< 4cm

    Treatment: Adjuvant radiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients
Plain-language title
Surgery Followed by Radiotherapy or Observation for Early-Stage Cervical CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04989647, who can take part
Record updated
7 September 2023