Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.

NCT07400809 | Recruiting DMC

• 1 other identifier: TMC IEC III 900891
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy; Treatment Compliance; Radiotherapy; Cervix Cancer; Surgery; Recurrent; Metastasis

Keywords

Recurrent and Metastatic Cervix Cancer; Oligo States

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (5)

• Infield Progression-Free Survival (PFS)

  4 years

• Overall Progression-Free Survival (PFS)

  4 years

• Dose-Response Relationship of Nodal and Visceral Progressions

  4 years

• Dose-Response Relationship in Re-irradiation Settings

  4 years

• Severe Adverse Events and Toxicity

  4 years

Study Arms (1)

Patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer and treated wit

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.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer and treated wit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Patient Compliance; Uterine Cervical Neoplasms; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Dr. Supriya Chopra, MD

  ACTREC, Tata Memorial Centre, Navi Mumbai India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Supriya Chopra, MD

CONTACT

9930958309; supriyasastri@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: August 23, 2023
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 14, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

IN (1)