A Phase III b randomized open-label trial on metformin for cancer prevention in adolescents and adults with Li-Fraumeni syndrome (LFS)

Conditions

Li-Fraumeni syndrome

Brief summary

Cancer-free survival (CFS) as time between randomization and “cancer” event defined as histologically confirmed cancer diagnosis established during trial participation or death from any cause

Detailed description

Tumor-free survival (TFS) as time between randomization and a “tumor” event including diagnosis of histologically confirmed cancer or clinically or radiologically detected benign or premalignant lesion identified during trial participation or death from any cause, Time from randomization to death from any cause during trial participation, Number and type of emerging cancers, including size, stage and histological grade at diagnosis, Treatment-emergent (serious) adverse events (AEs, SAEs), Levels of metformin adherence described by the aggregated MARS-5 scores, Change of QoL, FOP, levels of depression and anxiety and distress during the trial, Change in QoL, FOP, levels of depression and anxiety and distress from baseline to last visit, Correlation of baseline weight, BMI and lifestyle factors (e. g. smoking) with outcome

Related papers

No related papers found yet.

Interventions

DRUGMETFORMIN HYDROCHLORIDE

DRUGMETFORMIN

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cancer-free survival (CFS) as time between randomization and “cancer” event defined as histologically confirmed cancer diagnosis established during trial participation or death from any cause	—

Secondary

Measure	Time frame
Tumor-free survival (TFS) as time between randomization and a “tumor” event including diagnosis of histologically confirmed cancer or clinically or radiologically detected benign or premalignant lesion identified during trial participation or death from any cause, Time from randomization to death from any cause during trial participation, Number and type of emerging cancers, including size, stage and histological grade at diagnosis, Treatment-emergent (serious) adverse events (AEs, SAEs), Levels of metformin adherence described by the aggregated MARS-5 scores, Change of QoL, FOP, levels of depression and anxiety and distress during the trial, Change in QoL, FOP, levels of depression and anxiety and distress from baseline to last visit, Correlation of baseline weight, BMI and lifestyle factors (e. g. smoking) with outcome	—

Measure

Time frame

Tumor-free survival (TFS) as time between randomization and a “tumor” event including diagnosis of histologically confirmed cancer or clinically or radiologically detected benign or premalignant lesion identified during trial participation or death from any cause, Time from randomization to death from any cause during trial participation, Number and type of emerging cancers, including size, stage and histological grade at diagnosis, Treatment-emergent (serious) adverse events (AEs, SAEs), Levels of metformin adherence described by the aggregated MARS-5 scores, Change of QoL, FOP, levels of depression and anxiety and distress during the trial, Change in QoL, FOP, levels of depression and anxiety and distress from baseline to last visit, Correlation of baseline weight, BMI and lifestyle factors (e. g. smoking) with outcome

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Countries

Germany

Outcome results

None listed