Cervical CancerNCT06644846
Spatially Fractionated Radiation Treatment for Gynaecological Cancers
A study testing Spatially fractionated radiation therapy in people with Cervical Cancer and Gynecologic Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Gynecologic Cancer, Recurrent Cancer
- What is being tested?
- Spatially fractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 4 Oct 2024to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any pre-existing fistula in bladder or rectum.
- Pelvic prosthesis.
- Refusal to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
ACTREC Tata Memorial Centre
Navi Mumbai, Maharashtra, 410210
About this study
Official title: A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
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.
Read the detailed description
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 study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.
- Conditions
- Cervical Cancer, Gynecologic Cancer, Recurrent Cancer
- Being tested
- Spatially fractionated radiation therapy
- Keywords
- Cervical cancer, Cancer, Recurrence, Spatially fractionated radiotherapy, Rapid rod
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Spatially fractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-field control
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
Measured: 1-year
Secondary outcomes (5)
Progression-free and overall survival
To evaluate progression free and overall survival from the date of end of treatment upto 2 years
Measured: 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
Measured: > 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.
Measured: 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
Measured: 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
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start4 Oct 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention type: Spatially Fractionated Radiation Therapy (SFRT)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644846
- Sponsor's protocol ID
- TMC IEC III 900965
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
- ClinicalTrials.gov ID
- NCT06644846
- Acronym / sponsor ID
- TMC IEC III 900965
- Conditions
- Cervical Cancer, Gynecologic Cancer, Recurrent Cancer
- Keywords
- Cervical cancer, Cancer, Recurrence, Spatially fractionated radiotherapy, Rapid rod
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention type: Spatially Fractionated Radiation Therapy (SFRT)
| Arm | Type | Receives |
|---|---|---|
| SFRT arm | Experimental | Radiation: Spatially fractionated radiation therapyThis is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
- 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.
Key exclusion criteria (3 listed)
- Any pre-existing fistula in bladder or rectum.
- Pelvic prosthesis.
- Refusal to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially fractionated radiation therapySpatially 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. | Radiation | SFRT arm |
Primary outcome
In-field control
Time frame: 1-year
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
5 secondary outcomes
Progression-free and overall survival
Time frame: 2-years
Late grade 2 or higher genitourinary and gastrointestinal toxicities.
Time frame: > 90 days
To compare SFRT in-silico dose volume parameters with proton beam plans
Time frame: 1-year
To obtain biopsy tissue for translational research before and after SFRT
Time frame: 1-year
To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatially fractionated radiation therapy in people with Cervical Cancer and Gynecologic Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supriya Chopra, MD (022-68735000 ext. 5113, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-field control (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.