About this trial
Systemic chemotherapy with or without palliative radiation represents the current standard of care in patients with recurrent or metastatic cervix cancer. In addition, pelvic radiotherapy including brachytherapy is also recommended. There is no consensus on the treatment of metastatic site in patients with oligo-metastatic or oligo-recurrent cervix cancer. Also, it is not clear if addition of local treatment to systemic chemotherapy benefits all patients with metastatic disease or a select few with limited systemic disease burden. It's presently unclear which patients derive maximum benefit with integration of radiation at both primary and metastatic site, who develop infield recurrence if performing salvage surgery, locally directed treatments or re-irradiation in addition to systemic chemotherapy improves overall outcomes. The heterogeneity in clinical practice provides an important opportunity to develop a framework for data collection and future studies within such subgroup of patients. In this retrospective study, we aim to determine overall survival, Infield progression free survival, overall progression free survival, dose response relationship of nodal and visceral progressions, and within setting of re-irradiation (infield progressions), severe adverse events and toxicity, risk groups identification, a nomogram which correlates risk groups with expected outcomes, and framework for tissue collection for translational research Investigators will record the parameters in a predesigned proforma without including personal identifiers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cervical cancer with (induced) oligo-metastatic and/or oligo-recurrent cervix cancer whether treated or not treated with radiation. These patients may have received previous treatment within or outside approved clinical trials/studies.
Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.
Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression.
Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.
Disqualifiers
Gynaecological cancer other than cervical cancer.
Persistent Poly-metastatic disease post systemic treatment
Receiving investigational new drugs at the time of relapse as part of other ongoing trials.
No clinical follow up after treatment
Trial population
We aim to include all patients with (induced) oligo metastatic and oligo recurrent setting irrespective whether radiation was used or not with an aim to have different cohorts of patients based on interventions used. This will allow to better understand outcomes and radiation dose response if any. Also this provides an opportunity to better understand impact of radiation potentially through a matched pair analysis in future.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable- observational study
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
To determine the overall survival (OS) of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervical cancer treated with radiation or other local therapies, with or without systemic chemotherapy. Overall survival is defined as the time from registration to death from any cause or the last follow-up.
Secondary outcomes
Infield Progression-Free Survival (PFS)
Time from registration to progression of disease within the treated radiation or local therapy field, death from any cause, or last follow-up.
Overall Progression-Free Survival (PFS)
Time from registration to any disease progression (local, regional, or distant), death from any cause, or last follow-up.
Dose-Response Relationship of Nodal and Visceral Progressions
Evaluation of the relationship between radiation dose delivered and subsequent progression in nodal and visceral sites, with outcomes measured as time from registration to progression at these specific sites, death from any cause, or last follow-up.
Dose-Response Relationship in Re-irradiation Settings
Assessment of the correlation between radiation dose and infield progression in patients undergoing re-irradiation, measuring time to progression, death, or last follow-up.
Sponsors and contacts
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Tata Memorial Hospital
Lead sponsor
Erasmus Medical Center
Collaborator