NCT05421650 Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
| NCT ID | NCT05421650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHA University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2022-08-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
1\) 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. 2\) 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)
Contact & Investigator
Ju-Won Roh
PRINCIPAL INVESTIGATOR
CHA University Ilsan Medical Center
Frequently Asked Questions
Who can join the NCT05421650 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 70 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05421650 currently recruiting?
Yes, NCT05421650 is actively recruiting participants. Contact the research team at rohjuwon@hanmail.net for enrollment information.
Where is the NCT05421650 trial being conducted?
This trial is being conducted at Bengaluru, India, Rome, Italy, Târgu Mureş, Romania, Cheonan, South Korea and 11 additional locations.
Who is sponsoring the NCT05421650 clinical trial?
NCT05421650 is sponsored by CHA University. The principal investigator is Ju-Won Roh at CHA University Ilsan Medical Center. The trial plans to enroll 240 participants.
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