Clinical trial · Interventional
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB
Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patient enrollment goal will not be met
Summary
Brief summary (as posted)
The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.
Conditions
Conditions (15)
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 |
| Cervical Cancer Stage | — | UNRESOLVED | — |
| Cervical Cancer Stage I | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Cervical Cancer Stage IB | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Cervical Cancer Stage IB1 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Cervical Cancer Stage IB2 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Cervical Cancer Stage II | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Cervical Cancer Stage IIa |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Radiation Therapy
- description
- The patient will receive Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy.
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Number of Treatment-Related Symptoms of Post Traumatic Stress
- timeFrame
- 2 years
- description
- To quantify treatment-related symptoms of post traumatic stress to determine if stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven, invasive carcinoma of the cervix. * Candidate for pelvic, pelvic-inguinal, or extended field radiotherapy with or without concurrent chemotherapy. Patients undergoing preoperative or adjuvant chemotherapy are excluded. * History/physical examination within 60 days prior to registration to document cervical tumor size and stage * CT, MRI, or PET/CT imaging of the chest, abdomen, and pelvic regions within 60 days prior to registration (for stage I patients, PA and lateral chest x-ray is sufficient for chest imaging) * Age ≥ 18 * Negative serum pregnancy test for women of child-bearing potential * Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study. * Patients must sign informed consent prior to study entry. Exclusion Criteria: * Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields. * Prior hysterectomy. * Women who are pregnant or lactating are ineligible due to teratogenic effects on developing fetuses. Women who are of child-bearing potential need to practice effective methods of contraception including oral contraceptives, intrauterine device, diaphragm with spermicides, and/or abstinence. * Patients undergoing preoperative or adjuvant chemotherapy * History of pre-existing PTSD. * History of major psychiatric disorder.
References
Publications (0)
Data not yet available