Clinical trial · Interventional
Spatially Fractionated Radiation Treatment for Gynaecological Cancers
A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
- 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)
This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT. The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.
Conditions
Conditions (3)
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 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spatially fractionated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SFRT arm
- description
- This is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique.
- interventionNames
- Radiation: Spatially fractionated radiation therapy
Primary outcomes (1)
- measure
- In-field control
- timeFrame
- 1-year
- description
- To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
Secondary outcomes (5)
- measure
- Progression-free and overall survival
- timeFrame
- 2-years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to- 1. Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures. 2. Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2). 3. Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators. 2. Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as identified on pre-brachytherapy imaging obtained after EBRT. 3. Patients with large pelvic recurrences after surgery and/or (chemo) radiation, not amenable to surgical salvage or brachytherapy after salvage EBRT due to reasons specified in item 1. 4. Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events. Exclusion Criteria: 1. Any pre-existing fistula in bladder or rectum. 2. Pelvic prosthesis. 3. Refusal to provide consent.
References
Publications (0)
Data not yet available