Cervical Cancer
Conditions
Keywords
Cervical cancer, Image guided Brachytherapy, single application
Brief summary
The purpose of the study is to evaluate safety and feasibility of single brachytherapy application with dose delivery in multiple fractions. Study will be conducted in Phase I/II clinical trial setting with strict Image guidance protocol.This study is expected reduce treatment duration and to increase ease and acceptability of brachytherapy in patients along with significant saving of resources
Detailed description
Brachytherapy for cervical cancers has evolved a long way from the era of Manchester based point A prescription to volume-based prescription in the current era of 3 Dimensional (3D) imaging. Advancement in imaging technology and widespread availability of this technology has allowed most centers worldwide to incorporate Image guided brachytherapy as a routine part of their clinical practice. The primary advantage of 3D image guided brachytherapy is that it allows the dose given by brachytherapy to conform to the anatomy of each individual patient while reducing the doses to organs at risk (OAR) (1). This technique has shown to improve local control rates and also reduce the rates of moderate to severe morbidity in multiple single institutional series (2-6). However, treatment related urinary and gastrointestinal late morbidity is still a significant problem with the 3 year actuarial incidence of intermediate to major morbidity (Grade≥2) being 30% and 29% for urinary and gastrointestinal side effects, respectively and Major morbidity (Grade≥3) is seen in 7% and 8%, respectively \[An intErnational study on MRI guided BRachytherapy in locally Advanced CErvical cancers (EMBRACE) study 2014, work in progress(7)\]. Most important factor determining late toxicities in radiotherapy is dose per fraction and total dose (total BEDGy3) rather than rate of dose accumulation or number of applications, which is evident from many trials of HDR brachytherapy. The dose per fraction in the protocol of 9Gy, 7Gy and 7Gy HDR is effective in terms of local control rates and toxicities which has been published(8,9). Our study is designed to evaluate the feasibility to deliver complete course of HDR brachytherapy in a single application while achieving dose constraints to OARs and keeping in account inter-fraction variation of doses to OAR's. In the protocol proposed here, The Investigators intend to deliver fractionated treatments in a strict image based and quality controlled environment to minimize the doses to OAR's. Also if the constraints are not achieved, patients would be offered Standard brachytherapy regimen. This would ensure that the anticipated late toxicities would be minimized. This study is expected to decrease overall treatment time and increase the ease and acceptability of brachytherapy in patients and with significant saving of resources while maintaining disease control rates and toxicity rates similar to standard protocols.
Interventions
RADIATIONSingle application multi-fraction brachytherapy
Single application brachytherapy procedure to deliver high dose rate fractions of 9Gy, 7Gy and 7Gy with 6-12 hours apart under strict image guidance
Sponsors
Tata Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I/ Phase II single arm study
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma) * International Federation of Gynecology and Obstetrics (FIGO) stage 2b-4a after thorough clinical examination and work-up investigation * Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost * Accepts the Informed consent process and signs the form on his/her will.
Exclusion criteria
* Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis * Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI * Patients not suitable for brachytherapy * Metastatic disease beyond iliac on standard imaging * Vault cancers/recurrence * Previous history of pelvic radiation * Non-compliance to treatment * Medical or psychological illness precluding treatment protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieving specified dosimetric constraints | 1 year | Number of participants achieving protocol specified dosimetric constraints will be measured, these dosimetric constraints are considered as a measure of safety. If not more than 20% of participants fail to achieve dosimetric constraints, trial will be considered feasible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v 4.0 | 2 years | To assess toxicity outcomes in terms of treatment related late Gastrointestinal (GI) / Genitourinary (GU) / Vaginal toxicities (grade 3 or more) |
| Local control rate | 2 years | Status of local disease at 2 years after treatment |
| Percentage Inter-fraction dose variation | 1 year | To evaluate inter fraction dose variation for organs at risk |
Countries
India
Contacts
Primary ContactUmesh Mahantshetty, MD, DNB
Outcome results
None listed