Trial · NCT07883798
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic progression-free survival (rPFS) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to first radiographic progression at any site or death from any cause. Participants without an event are censored at the last reliable radiographic assessment. Clinical progression without imaging is recorded separately and considered in sensitivity analyses. |
| Secondary | Polymetastatic progression-free survival: classical threshold (PMFS-C5) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to more than 5 total active metastatic lesions, diffuse or uncountable disease, or death. Evaluated only in participants with 1-5 active metastatic lesions at the qualifying oligometastatic disease assessment (T0-OMD). The threshold uses total active metastatic burden, not only newly detected lesions. |
| Secondary | Polymetastatic progression-free survival: extended threshold (PMFS-E10) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to more than 10 total active metastatic lesions, diffuse or uncountable disease, or death. Evaluated in the positron emission tomography (PET)-defined cohort with 1-10 lesions. The expanded positron emission tomography-defined polymetastatic progression threshold (PMD-E10) status is indeterminate when follow-up imaging cannot assess the threshold, unless more than 10 lesions or diffuse disease is unequivocal. |
| Secondary | Time to loss of the oligometastatic state (TLOMS) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to loss of the oligometastatic state through progression to the applicable polymetastatic threshold or diffuse disease. Death is treated as a competing event in the disease-state estimand. |
| Secondary | Systemic therapy start or switch-free survival (SST-FS) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to initiation of systemic anticancer treatment, a change in treatment line, escalation of the systemic strategy, or death. Event rules depend on the baseline systemic-treatment setting. |
| Secondary | Overall survival (OS) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to death from any cause. |
| Secondary | Treated-lesion local control | From the first radiotherapy fraction or brachytherapy application to each lesion, assessed for up to 5 years. | Time from the first radiotherapy fraction or brachytherapy application to the individual lesion to unequivocal in-field progression. Death without lesion progression is treated as a competing event. Lesions are assessed individually. |
| Secondary | Pattern of first progression | At first progression after the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), during follow-up of up to 5 years. | Description of first progression by anatomical site, number of active lesions, detection modality, local feasibility of subsequent metastasis-directed therapy, and oligometastatic or polymetastatic disease status. |
| Secondary | Systemic therapy-free survival (STFS) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Among participants without active systemic treatment at the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), time to initiation of any systemic anticancer treatment or death. |
| Secondary | Time to next systemic therapy line (TTNSL) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to the first new systemic treatment line after the index strategy. Continuation of a regimen started as part of the index strategy is not an event until treatment is changed or escalated. |
| Secondary | Time to initiation or change of cytotoxic chemotherapy | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to initiation or change of cytotoxic chemotherapy. Continuation of non-cytotoxic treatment is not an event. |
| Secondary | Maintenance treatment strategy preservation interval (MTPI) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Among participants receiving maintenance or continuing therapy, time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to permanent discontinuation, escalation or change of that strategy because of progression, an adverse event or a clinical decision. A temporary hold followed by resumption of the same therapy is not an event. |
| Secondary | Time to subsequent metastasis-directed therapy (TTMDT) | From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years. | Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to subsequent metastasis-directed treatment, particularly a subsequent course of radiotherapy. |
| Secondary | Complete response of treated lesions | Approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy. | Complete response assessed separately for treated lesions at approximately 3 and 6 months after completion of radiotherapy, according to local practice, preferably Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), supplemented by metabolic criteria when positron emission tomography (PET) is used. |
| Secondary | Patient-level complete response | Approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy. | Complete response at participant level assessed at approximately 3 and 6 months after completion of radiotherapy, according to local practice, preferably Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), supplemented by metabolic criteria when positron emission tomography (PET) is used. |
| Secondary | Acute adverse events | From initiation of radiotherapy through 90 days after completion of index radiotherapy. | Acute adverse events characterized by term, grade, dates, seriousness, attribution, intervention, hospitalization, treatment interruption and outcome. Baseline events are recorded separately. The Common Terminology Criteria for Adverse Events, version 6.0 (CTCAE v6.0) are used for prospectively collected data; historical data retain the source version and are mapped only when reliable. |
| Secondary | Late adverse events | More than 90 days after completion of index radiotherapy, assessed during follow-up of up to 5 years. | Adverse events occurring more than 90 days after completion of radiotherapy, characterized by term, grade, dates, seriousness, attribution, intervention and outcome. The Common Terminology Criteria for Adverse Events, version 6.0 (CTCAE v6.0) are used for prospectively collected data; historical data retain the source version and are mapped only when reliable. |
| Secondary | Disease-burden reclassification associated with positron emission tomography (PET) | At baseline, using computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) performed no more than 28 days apart, without intervening treatment that changes disease burden. | Reclassification of the number of active metastatic lesions between 1-5, 6-10, and more than 10 or diffuse-disease categories after incorporating fluorodeoxyglucose positron emission tomography (FDG-PET). Paired computed tomography/magnetic resonance imaging (CT/MRI)-PET comparisons require scans no more than 28 days apart without intervening treatment that changes disease burden. |
| Secondary | Management change associated with positron emission tomography (PET) | During qualifying baseline staging and planning for the index radiotherapy strategy. | Positron emission tomography (PET)-associated changes in eligibility, treatment intent, target selection, radiation fields or systemic-treatment strategy for the index episode. |
| Secondary | Discordance between conventional imaging and fluorodeoxyglucose positron emission tomography (FDG-PET) | At baseline, using computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) performed no more than 28 days apart, without intervening treatment that changes disease burden. | Differences between computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) in the number and anatomical location of active metastatic lesions, assessed in the paired-imaging population. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07883798/registered