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Tests surgery to remove cancerous lymph nodes before chemoradiation for cervical cancer

Tests removing enlarged cancer-affected lymph nodes before chemoradiation in women with cervical cancer.

Key facts

Who runs it
CHA University
Where
Rome, ItalySee the siteAlso in 4 other countries, 25 sites
Trial code
Registry title
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Status
Recruiting
People taking part
240 people, planned
Started
1 Aug 2022
Expected to end
31 Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CCRT
  • Surgical debulking of lymph nodes + CCRT
Record updated
9 April 2025

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 with newly diagnosed cervical cancer that has spread to enlarged or several lymph nodes and who are planned to get chemoradiation. It tests removing the lymph nodes by surgery first.

Age
20 to 70 years
Sex
Women only
Disease stage
Newly diagnosed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix (stage IIICr). Pelvic or para-aortic lymph node with a short axis of 1.5 cm (0.6 in) or more, or 2 or more nodes with a short axis of 1 cm (0.4 in) or more, on CT or MRI. Scans must show the nodes can be removed by surgery.
Earlier treatment
Concurrent chemoradiation (CCRT) must be planned as the treatment. People who had radiotherapy to the pelvis before cannot join.

Main reasons for not taking part

  • Another cancer in the past 5 years (thyroid cancer and stage 0 cancer are not counted)
  • Pregnant or planning to become pregnant during the trial
  • Active infection or severe inflammation that cannot be cured
  • Cannot have surgery or chemotherapy because of another illness
  • Cancer spread beyond the pelvic or para-aortic lymph nodes, for example to lung, subclavian or inguinal nodes

The registry criteria, word for word

Show all 2 criteriaShow less

Other criteria

  • Inclusion Criteria; (1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination
  • Exclusion Criteria; (1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)

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 20 and 70 years old?

Where in Italy

Also in 4 other countries, 25 sites

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyContact: Nicolò Bizzarri (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.

The 2 groups in the trial

  • Control groupExisting treatment, for comparison

    Concurrent chemoradiation therapy (CCRT)

    Treatment: CCRT

  • Experimental groupTreatment being tested

    Surgical debulking of bulky or multiple lymph node + CCRT

    Treatment: Surgical debulking of lymph nodes + CCRT

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.
Official title
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial
Plain-language title
Tests surgery to remove cancerous lymph nodes before chemoradiation for 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 NCT05421650, who can take part
Record updated
9 April 2025