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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| In-field control | To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Supriya Chopra, MD | Contact | 022-68735000 | 5113 | supriyasastri@gmail.com |
| Ankita Gupta, MD | Contact | 9592750011 | ankita19.gupta.ag@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTREC Tata Memorial Centre | Recruiting | Navi Mumbai | Maharashtra | 410210 | India |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Intervention type: Spatially Fractionated Radiation Therapy (SFRT)
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|
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 |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |