NCT07400809 Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.
| NCT ID | NCT07400809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Hospital |
| Condition | Chemotherapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2027-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2023-08-23 with a primary completion date of 2027-06-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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. 2. Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site. 3. Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression. 4. Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted. Exclusion Criteria: 1. Gynaecological cancer other than cervical cancer. 2. Persistent Poly-metastatic disease post systemic treatment 3. Receiving investigational new drugs at the time of relapse as part of other ongoing trials. 4. No clinical follow up after treatment
Contact & Investigator
Dr. Supriya Chopra, MD
PRINCIPAL INVESTIGATOR
ACTREC, Tata Memorial Centre, Navi Mumbai India
Frequently Asked Questions
Who can join the NCT07400809 clinical trial?
This trial is open to participants of all sexes, studying Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07400809 currently recruiting?
Yes, NCT07400809 is actively recruiting participants. Contact the research team at supriyasastri@gmail.com for enrollment information.
Where is the NCT07400809 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT07400809 clinical trial?
NCT07400809 is sponsored by Tata Memorial Hospital. The principal investigator is Dr. Supriya Chopra, MD at ACTREC, Tata Memorial Centre, Navi Mumbai India. The trial plans to enroll 350 participants.