Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICr: A phase III, randomized controlled clinical trial (DEBULK trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007137

Enrollment

234

Registered

2022-03-31

Start date

2022-10-31

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Standard treatment group (control): Concurrent chemoradiation therapy (CCRT) Radiation therapy consisting of external beam radiotherapy (EBRT) (total 45-50.4 Gy) and intracavitary

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Women =20 years and = 70 years of age (2) Newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (3) When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic LN or paraaortic LN under the renal vein is = 2cm, or more than 3 LNs with a short axis = 1 cm (4) When CCRT is planned as a treatment for cervical cancer (5) A 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 surgical debulking is possible for LN metastasis as confirmed by radiological examination

Exclusion criteria

Exclusion criteria: (1) A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) A patient that is pregnant or plans to become pregnant during the clinical study period (3) A patient with any active infectious disease or incurable severe inflammation. (4) When surgery is not possible due to internal or surgical disease (5) When chemotherapy is impossible due to internal or surgical disease (6) A patient with a history of pelvic radiation therapy (7) A patient with a history of subtotal hysterectomy (8) A patient with a remote metastasis other than a pelvic lymph node or paraaortic lymph node (Ex. Lung, subclavian lymph node, inguinal lymph node)

Design outcomes

Primary

Measure	Time frame
3-year progression-free survival (PFS) and 3-year overall survival (OS)	—

Secondary

Measure	Time frame
Treatment-related complications;Measurement of imaging accuracy of bulky or multiple lymph nodes	—

Countries

Korea, Republic of

Contacts

Public ContactJu-Won Roh

CHA University

rohjuwon@hanmail.net+82-2-512-5444

Outcome results