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New treatment option for Cervical Cancer
Official title Spatially Fractionated Radiation Treatment for Gynaecological Cancers
ClinicalTrials.gov ID: NCT06644846
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
- Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two...
- Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on...
- Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
- Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as...
You likely can't join if
- Any pre-existing fistula in bladder or rectum.
- Pelvic prosthesis.
- Refusal to provide consent.
See the full eligibility criteria
- Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
- 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.
- 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).
- Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
- 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.
- 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.
- Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.
- Any pre-existing fistula in bladder or rectum.
- Pelvic prosthesis.
- Refusal to provide consent.
The study team makes the final eligibility decision.
Where it's taking place
- Navi Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Navi Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.