Evaluating surgery with or without additional radiotherapy for intermediate risk cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to determine whether adjuvant (chemo)radiotherapy improves disease-free survival in patients with intermediate risk cervical cancer after radical surgery. A total of 514 patients will be enrolled and randomly assigned to receive either no additional treatment or adjuvant radiotherapy following surgery. The study will assess the primary endpoint of disease-free survival using a Cox proportional hazards model, with a focus on providing high-quality evidence regarding the effectiveness of adjuvant treatment in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed invasive cervical cancer
* FIGO IB1-IIA
* Squamous cell cancer or HPV-related adenocarcinoma
* Presence of tumour-related risk factors as follows:

  1. tumour ≥4 cm OR
  2. tumour\>2 cm \<4 cm AND lymphovascular space invasion OR
  3. tumour \>2 cm \<4 cm AND tumour free distance \<3 mm OR
  4. 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)

Exclusion Criteria:

* 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
* Unequivocally positive lymph node by imaging (by radiological subjective assessment)
* FIGO \<IB1 / \>IIA
* Previous pelvic malignancy
* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
* Previous pelvic radiotherapy
* Neoadjuvant chemotherapy prior surgical treatment
* Low likelihood of patient compliance to the follow-up

Where it's running

• General University Hospital in Prague
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: David Cibula, prof. — General University Hospital in Prague, Czech Republic
• Study coordinator: Martina Borcinova, PhD
• Email: martina.borcinova@cervantes-trial.com
• Phone: +420224969298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.