Health TrialsbyHealthPanel

Spatially Fractionated Radiation Treatment for Gynaecological Cancers

ConditionsCervical CancerGynecologic CancerRecurrent Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTata Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Any pre-existing fistula in bladder or rectum.

Pelvic prosthesis.

Refusal to provide consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Spatially fractionated radiation therapy

    Radiation

    Spatially fractionated" radiation therapy (SFRT) enables delivery of high-dose radiation to discrete sub-volumes inside a tumour target while restricting the remainder of the target to a safer lower dose. This technique results in generation of intentionally heterogeneous dose distribution with spatial areas of "hot" and "cold" spots within the tumour, thereby sparing nearby organs at risk.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SFRT armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

In-field control

To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT

Time frame
1-year

Secondary outcomes

1

Progression-free and overall survival

To evaluate progression free and overall survival from the date of end of treatment upto 2 years

Time frame
2-years
2

Late grade 2 or higher genitourinary and gastrointestinal toxicities.

To evaluate grade 2 or higher genitourinary and gastrointestinal toxicities from the date of end of treatment upto 90 days

Time frame
> 90 days
3

To compare SFRT in-silico dose volume parameters with proton beam plans

To compare dose volume parameters of SFRT plans with proton beam plans, created on the same datasets.

Time frame
1-year
4

To obtain biopsy tissue for translational research before and after SFRT

Programmed cell death ligand 1 (PD-L-1) expression will be studied

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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