ChemotherapyRetro-COSMOSNCT07400809
Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.
An observational study of Chemotherapy and Treatment Compliance, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chemotherapy, Treatment Compliance, Radiotherapy
- What is being tested?
- Not applicable- observational study
- How many people
- 350 participants
- Where
- 1 siteIndia
- Study dates
- 23 Aug 2023to 14 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Dr Supriya Chopra, MD, 9930958309, supriyasastri@gmail.com
About this study
Official title: Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.
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.
Read the detailed description
This is a multicentric, retrospective registry designed to evaluate clinical outcomes in patients with (induced) oligo-metastatic and oligo-recurrent cervical cancer. These patients will be identified using an adapted ESTRO-ASTRO consensus definition. The study aims to investigate the role of radiation therapy-whether high-dose, stereotactic ablative, or re-irradiation-in combination with or without systemic chemotherapy, immunotherapy, or targeted agents, in improving survival outcomes and minimizing treatment-related toxicity. Despite systemic chemotherapy being the current standard for metastatic cervical cancer, the survival benefits remain modest. Emerging evidence, including findings from the SABR-COMET trial and institutional experiences, suggests that selected patients with limited metastatic burden may derive survival benefit from integration of local therapies. However, for cervical cancer specifically, there is limited consensus on the optimal use of radiation in the oligometastatic or oligorecurrent setting.
This registry seeks to capture real-world data from EMBRACE-participating centers to explore treatment patterns, dose-response relationships, and toxicity profiles. The primary objective is to determine overall survival, with secondary endpoints including in-field and overall progression-free survival, treatment-related toxicity, and development of prognostic risk groups. The registry will also support development of a nomogram and a framework for future translational research, including tissue collection. Data will be collected through a centralized, secure electronic data capture system (Castor EDC) hosted at Erasmus University Medical Center. Each participating site will enter anonymized patient data into standardized case report forms derived from patient records. Built-in data validation rules and consistency checks will be used to ensure data quality, with each center responsible for accuracy and source verification. A central data dictionary standardizes variable definitions and coding. The data will be managed under established standard operating procedures covering data collection, quality control, and analysis. Statistical analysis will include descriptive summaries, Kaplan-Meier survival curves, Cox regression modeling, and dose-response assessments. Approximately 350-400 patients treated between 2007 and 2021 are expected to be included. The registry does not involve direct patient contact and poses minimal risk, with all ethical approvals and data protection safeguards in place, including local IRB clearance and waiver of consent where applicable. This registry aims to inform future clinical trials and guidelines for personalized treatment in oligo-metastatic and oligo-recurrent cervical cancer.
- Conditions
- Chemotherapy, Treatment Compliance, Radiotherapy, Cervix Cancer, Surgery, Recurrent
- Being tested
- Not applicable- observational study
- Keywords
- Recurrent and Metastatic Cervix Cancer, Oligo States
- Medical subject headings
- Patient Compliance, Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (5)
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.
Measured: 4 years
Overall Progression-Free Survival (PFS)
Time from registration to any disease progression (local, regional, or distant), death from any cause, or last follow-up.
Measured: 4 years
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.
Measured: 4 years
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.
Measured: 4 years
Severe Adverse Events and Toxicity
Evaluation and documentation of grade ≥3 treatment-related adverse events and toxicities occurring during or after therapy.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start23 Aug 2023
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Hospital
- Investigators
- Dr. Supriya Chopra, MD, Principal investigator, ACTREC, Tata Memorial Centre, Navi Mumbai India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400809
- Sponsor's protocol ID
- TMC IEC III 900891
- Acronym
- Retro-COSMOS
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.
- ClinicalTrials.gov ID
- NCT07400809
- Acronym / sponsor ID
- Retro-COSMOS / TMC IEC III 900891
- Conditions
- Chemotherapy, Treatment Compliance, Radiotherapy, Cervix Cancer, Surgery, Recurrent
- Keywords
- Recurrent and Metastatic Cervix Cancer, Oligo States
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Erasmus Medical Center
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicentric, retrospective registry designed to evaluate clinical outcomes in patients with (induced) oligo-metastatic and oligo-recurrent cervical cancer. These patients will be identified using an adapted ESTRO-ASTRO consensus definition. The study aims to investigate the role of radiation therapy-whether high-dose, stereotactic ablative, or re-irradiation-in combination with or without systemic chemotherapy, immunotherapy, or targeted agents, in improving survival outcomes and minimizing treatment-related toxicity. Despite systemic chemotherapy being the current standard for metastatic cervical cancer, the survival benefits remain modest. Emerging evidence, including findings from the SABR-COMET trial and institutional experiences, suggests that selected patients with limited metastatic burden may derive survival benefit from integration of local therapies. However, for cervical cancer specifically, there is limited consensus on the optimal use of radiation in the oligometastatic or oligorecurrent setting.
This registry seeks to capture real-world data from EMBRACE-participating centers to explore treatment patterns, dose-response relationships, and toxicity profiles. The primary objective is to determine overall survival, with secondary endpoints including in-field and overall progression-free survival, treatment-related toxicity, and development of prognostic risk groups. The registry will also support development of a nomogram and a framework for future translational research, including tissue collection. Data will be collected through a centralized, secure electronic data capture system (Castor EDC) hosted at Erasmus University Medical Center. Each participating site will enter anonymized patient data into standardized case report forms derived from patient records. Built-in data validation rules and consistency checks will be used to ensure data quality, with each center responsible for accuracy and source verification. A central data dictionary standardizes variable definitions and coding. The data will be managed under established standard operating procedures covering data collection, quality control, and analysis. Statistical analysis will include descriptive summaries, Kaplan-Meier survival curves, Cox regression modeling, and dose-response assessments. Approximately 350-400 patients treated between 2007 and 2021 are expected to be included. The registry does not involve direct patient contact and poses minimal risk, with all ethical approvals and data protection safeguards in place, including local IRB clearance and waiver of consent where applicable. This registry aims to inform future clinical trials and guidelines for personalized treatment in oligo-metastatic and oligo-recurrent cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer and treated wit | – | Other: Not applicable- observational study1. 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer and treated wit |
Primary outcome
Overall survival
Time frame: 4 years
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.
5 secondary outcomes
Infield Progression-Free Survival (PFS)
Time frame: 4 years
Overall Progression-Free Survival (PFS)
Time frame: 4 years
Dose-Response Relationship of Nodal and Visceral Progressions
Time frame: 4 years
Dose-Response Relationship in Re-irradiation Settings
Time frame: 4 years
Severe Adverse Events and Toxicity
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Supriya Chopra, MD principal investigator
ACTREC, Tata Memorial Centre, Navi Mumbai India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy and Treatment Compliance, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Supriya Chopra, MD (9930958309, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.