Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

Overview

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.

Description

Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial).

• Concurrent chemoradiation therapy (CCRT)
• Surgical debulking of bulky or multiple lymph node followed by CCRT

Eligibility

1. Inclusion Criteria
   1. Women ≥20 years and ≤ 70 years of age
   2. Cervical histopathology results of newly diagnosed squamous cell carcinoma, glandular epithelial cell, or adenosquamous carcinoma
   3. When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic lymph node or paraaortic lymph node under the renal vein is ≥ 2cm, or more than 3 lymph nodes with a short axis ≥ 1 cm
   4. When concurrent chemoradiation therapy is planned as a treatment for cervical cancer
   5. Patient whose competency is ECOG performance score 0-1
   6. A patient which has signed the approved informed consent form for study subjects
   7. A patient for which it is determined that pre-surgical debulking is possible for lymph node metastasis as confirmed by radiological examination
   8. Exclusion Criteria
   9. A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years
   10. A patient that is pregnant or plans to become pregnant during the clinical study period
   11. A patient with any active infectious disease or incurable severe inflammation.
   12. When surgery is not possible due to internal or surgical disease
   13. When chemotherapy is impossible due to internal or surgical disease
   14. Patient with a history of pelvic radiation therapy
   15. Patient with a history of subtotal hysterectomy