FaR-RMS: An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma

Conditions

Rhabdoyosarcoma

Brief summary

Recommended Phase 2 Dose (RP2D) - Phase 1b, Event Free Survival for randomisations CT1a, CT1b, CT2, RT2 and CT3, Local failure free survival for randomisations RT1a, RT1b and RT1c

Detailed description

Maximum Tolerated Dose for registration phase 1b, Dose Limiting Toxicity for registration phase 1b, Overall Survival for all patients, randomisations CT1a, CT1b, CT2, CT3, RT1a, RT1b, RT1c and also RT, Event Free Survival for all patients, randomisations RT1a, RT1b, RT1c and also the PET sub-study, Loco-regional failure-free survival for randomisations RT1a, RT1b, RT1c and RT2, Local failure free survival for the PET sub-study, Response for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Best Response for randomisation CT3, Duration of response for randomisation CT3, Toxicity for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Acute post-radiotherapy complications for randomisations RT1a, RT1b, RT1c and RT2, Late complications for randomisations RT1a, RT1b and RT1c, Acute post-operative complications for randomisations RT1a and RT1b, Wound complications for randomisations RT1a and RT1b, Health Related Quality of Life for randomisations RT1a and RT2, PET response for the PET sub-study

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIRINOTECAN

DRUGCYCLOPHOSPHAMIDE

DRUGRegorafenib_PIP

DRUGIFOSFAMIDE

DRUGTEMOZOLOMIDE

DRUGREGORAFENIB

DRUGDOXORUBICIN

DRUGDACTINOMYCIN

DRUGVINORELBINE TARTRATE

DRUGVINCRISTINE SULFATE

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recommended Phase 2 Dose (RP2D) - Phase 1b, Event Free Survival for randomisations CT1a, CT1b, CT2, RT2 and CT3, Local failure free survival for randomisations RT1a, RT1b and RT1c	—

Secondary

Measure	Time frame
Maximum Tolerated Dose for registration phase 1b, Dose Limiting Toxicity for registration phase 1b, Overall Survival for all patients, randomisations CT1a, CT1b, CT2, CT3, RT1a, RT1b, RT1c and also RT, Event Free Survival for all patients, randomisations RT1a, RT1b, RT1c and also the PET sub-study, Loco-regional failure-free survival for randomisations RT1a, RT1b, RT1c and RT2, Local failure free survival for the PET sub-study, Response for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Best Response for randomisation CT3, Duration of response for randomisation CT3, Toxicity for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Acute post-radiotherapy complications for randomisations RT1a, RT1b, RT1c and RT2, Late complications for randomisations RT1a, RT1b and RT1c, Acute post-operative complications for randomisations RT1a and RT1b, Wound complications for randomisations RT1a and RT1b, Health Related Quality of Life for randomisations RT1a and RT2	—

Measure

Time frame

Maximum Tolerated Dose for registration phase 1b, Dose Limiting Toxicity for registration phase 1b, Overall Survival for all patients, randomisations CT1a, CT1b, CT2, CT3, RT1a, RT1b, RT1c and also RT, Event Free Survival for all patients, randomisations RT1a, RT1b, RT1c and also the PET sub-study, Loco-regional failure-free survival for randomisations RT1a, RT1b, RT1c and RT2, Local failure free survival for the PET sub-study, Response for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Best Response for randomisation CT3, Duration of response for randomisation CT3, Toxicity for registration phase 1b and also randomisations CT1a, CT1b, and CT3, Acute post-radiotherapy complications for randomisations RT1a, RT1b, RT1c and RT2, Late complications for randomisations RT1a, RT1b and RT1c, Acute post-operative complications for randomisations RT1a and RT1b, Wound complications for randomisations RT1a and RT1b, Health Related Quality of Life for randomisations RT1a and RT2

—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden

Outcome results

None listed