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Die klinische Studie NCT06644846 für Zervixkarzinom, Gynäkologischer Krebs, Rezidivierter Krebs ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Spatially Fractionated Radiation Treatment for Gynaecological Cancers 20

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Die klinische Studie NCT06644846 ist eine interventionsstudie zur Untersuchung von Zervixkarzinom, Gynäkologischer Krebs, Rezidivierter Krebs und hat den Status offene rekrutierung. Die Studie startete am 4. Oktober 2024 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Tata Memorial Hospital ist der Abschluss für 28. Februar 2029 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 20. Februar 2026 aktualisiert.
Kurzbeschreibung
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 ti...

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Ausführliche Beschreibung
Patients will be treated with spatially fractionated radiation therapy (SFRT) after EBRT completion to a dose of 25-30 Gy in 5-6 fractions in the primary setting. For patients receiving re-irradiation, 20-25 Gy in 4-5 fractions will be delivered with SFRT, which however may be individualised to match with clinical practice in the re-RT setting. Total EQD2 Gy for organs at risk will be matched to brachytherapy.

The s...

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Offizieller Titel

A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers

Erkrankungen
ZervixkarzinomGynäkologischer KrebsRezidivierter Krebs
Weitere Studien-IDs
  • TMC IEC III 900965
NCT-Nummer
NCT06644846
Studienbeginn (tatsächlich)
2024-10-04
Zuletzt aktualisiert
2026-02-20
Studienende (vorauss.)
2029-02-28
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Cervical cancer
Cancer
Recurrence
Spatially fractionated radiotherapy
Rapid rod
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellSFRT arm
This is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique.
Spatially fractionated radiation therapy
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
In-field control
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
1-year
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Progression-free and overall survival
To evaluate progression free and overall survival from the date of end of treatment upto 2 years
2-years
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
> 90 days
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.
1-year
To obtain biopsy tissue for translational research before and after SFRT
Programmed cell death ligand 1 (PD-L-1) expression will be studied
1-year
To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT
To evaluate overall response based on PET-FDG and hypoxia markers at baseline and before SFRT
1-year
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich

  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.

  1. Any pre-existing fistula in bladder or rectum.
  2. Pelvic prosthesis.
  3. Refusal to provide consent.
Tata Memorial Hospital logoTata Memorial Hospital
Verantwortliche Partei
Supriya Sastri (chopra), Hauptprüfer, Dr Supriya Sastri, Tata Memorial Hospital
Zentrale Studienkontakte
Kontakt: Supriya Chopra, MD, 022-68735000, [email protected]
Kontakt: Ankita Gupta, MD, 9592750011, [email protected]
1 Studienstandorte in 1 Ländern

Maharashtra

ACTREC Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India
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