A PROSPECTIVE PHASE 2 CLINICAL TRIAL OF INTRA-LESIONAL CERVICAL TUMOR BOOST FOR BULKY CERVICAL CANCER (INTLECTUAL trial)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0010319

Enrollment

Registered

2025-03-20

Start date

2025-02-03

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

None listed

Interventions

Radiation : Intra-lesional boost using SIB technique 15 Gy/3 Fx Radiation dose prescription - Whole pelvis (+/- para-aortic field) 45-50.4 Gy/25-28 fx with 15 Gy/3 fx Intra-lesional boost using simu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Squamous cell carcinoma with tumor volume =60 cc or longest diameter =6 cm, consenting to participate. 2. Aged 19–80 years. 3. ECOG performance status 0–2.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Diagnosed with other cancers within five years (except breast carcinoma in situ or thyroid cancer). 2. Ineligible for definitive CCRT. 3. Prior chemotherapy before radiation. 4. Unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Pre-brachytherapy tumor volume	—

Secondary

Measure	Time frame
Complete response rate;Local recurrence rate;progression-free survival (PFS);overall survival (OS); treatment-related toxicity	—

Countries

Korea, Republic of

Contacts

Public ContactKeun-Yong Eom

Seoul National University Bundang Hospital

978sarang@hanmail.net+82-31-787-7653

Outcome results