Clinical trial · Interventional
Intra-lesional Tumor Boost for Bulky Cervical Cancer
A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are: * Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment? Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual. Participants will: * Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Squamous Cell Carcinoma of Cervix | Cervical Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Rate Brachytherapy | Procedure | — | UNRESOLVED |
| intra-lesional boost IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-lesional Boost Group
- interventionNames
- Radiation: intra-lesional boost IMRT
- Procedure: High Dose Rate Brachytherapy
Primary outcomes (1)
- measure
- Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy
- timeFrame
- At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)
- description
- Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc.
Secondary outcomes (5)
- measure
- Complete Remission (CR) Rate
- timeFrame
- From treatment completion up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed squamous cell carcinoma of the cervix. * Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm. * Patients aged 19 to 80 years at the time of diagnosis. * Patients with an ECOG performance status of 0 to 2. * Patients who have voluntarily agreed to participate in the study. Exclusion Criteria: * Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer). * Patients who are medically unfit for definitive concurrent chemoradiotherapy. * Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy. * Patients with prior history of radiation therapy to the abdomen or pelvis. * Patients unable to provide informed consent due to mental or physical disabilities.
References
Publications (0)
Data not yet available