NCT06644846

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
35mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Oct 2024Feb 2029

First Submitted

Initial submission to the registry

July 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

July 12, 2024

Last Update Submit

February 18, 2026

Conditions

Cervical CancerGynecologic CancerRecurrent Cancer

Keywords

Cervical cancerCancerRecurrenceSpatially fractionated radiotherapyRapid rod

Outcome Measures

Primary Outcomes (1)

  • In-field control

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

    1-year

Secondary Outcomes (5)

  • Progression-free and overall survival

    2-years

  • Late grade 2 or higher genitourinary and gastrointestinal toxicities.

    > 90 days

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

    1-year

  • To obtain biopsy tissue for translational research before and after SFRT

    1-year

  • To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT

    1-year

Study Arms (1)

SFRT arm

EXPERIMENTAL

This is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique.

Radiation: Spatially fractionated radiation therapy

Interventions

Spatially fractionated radiation therapyRADIATION

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.

SFRT arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

  • Any pre-existing fistula in bladder or rectum.
  • Pelvic prosthesis.
  • Refusal to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACTREC Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRecurrenceNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Supriya Chopra, MD

CONTACT

022-68735000supriyasastri@gmail.com

Ankita Gupta, MD

CONTACT

9592750011ankita19.gupta.ag@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intervention type: Spatially Fractionated Radiation Therapy (SFRT)
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Supriya Sastri

Study Record Dates

First Submitted

July 12, 2024

First Posted

October 16, 2024

Study Start

October 4, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2029

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)