Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.
Recruiting now
Conditions studied: Chemotherapy, Treatment Compliance, Radiotherapy, Cervix Cancer, Surgery, Recurrent, Metastasis
In brief
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.
Key facts
- Study ID
- NCT07400809
- Run by
- Tata Memorial Hospital
- People needed
- 350
- Starts
- 2023-08-23
- Expected to finish
- 2027-06-14
- Last updated by the study team
- 2026-02-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Tata Memorial Hospital — Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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