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Spots Global Cancer Trial Database for Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

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Trial Identification

Brief Title: Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

Official Title: Phase II Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

Study ID: NCT05131386

Interventions

Trabectedin

Study Description

Brief Summary: Phase II, multicohort, single arm, open-label, multicenter, international clinical trial with three cohorts (cohort A: Soft tissue sarcoma, cohort B: Bone tumors (osteosarcoma, chondrosarcoma and cohort C: Small round-cell sarcomas (Ewing's sarcoma, rhabdomyosarcoma, desmoplastic small round-cell tumors and other small round cell sarcomas)) with 7 sites in Spain. Main objective: To evaluate the overall response rate (ORR) in the irradiated nodules according to RECIST v1.1 criteria. Treatment Medication Trabectedin at 1.5 mg/m2 24-h IV CI along with radiation therapy (30 Gy, 3 Gy/day for 10 days for non-extremity location and 45 Gy, 1.8 Gy/day for 25 days for extremity location of target lesion(s)), starting within 1 hour after the first trabectedin infusion withdrawal (day 2)) will be given every 3 weeks up to progression or intolerance. Premedication 4 mg oral dexamethasone 24h and 12h before trabectedin administration, 20 mg IV dexamethasone 30 minutes before treatment. Ondansetron or analogue will also be given prior to trabectedin.

Detailed Description: Cohort A: Soft tissue sarcomas (2nd or further line): A proportion of 10% of ORR will be considered as not promising, whereas an ORR of 35% will be considered promising in this population. With a type I error α of 0.05 and a power of 0.90, 27 patients were estimated in this cohort. With Simon's two-stage optimal design,36 at least 2 responses have to be obtained over the 11 first patients. Then, additional 16 eligible patients will be accrued up to 27 patients. If at least 6 patients show response, further investigation of this scheme is warranted. Cohort B: Bone tumors (osteosarcoma, chondrosarcoma) (2nd or further line): A proportion of 3% of ORR will be considered as not promising, whereas an ORR of 20% will be considered promising in this population. With a type I error α of 0.05 and a power of 0.90, 29 patients were estimated in this cohort. With Simon's two-stage optimal design,36 at least 1 response has to be obtained over the 12 first patients. Then, additional 17 eligible patients will be accrued up to 29 patients. If at least 3 patients show response, further investigation of this scheme is warranted. Cohort C: Small round-cell sarcomas (Ewing's sarcoma, rhabdomyosarcoma, desmoplastic small round-cell tumors and other small round-cell sarcomas) (3rd or further line): A proportion of 15% of ORR will be considered as not promising, whereas an ORR of 40% will be considered promising in this population. With a type I error α of 0.05 and a power of 0.90, 29 patients were estimated in this cohort. With Simon's two-stage optimal design,36 at least 3 response has to be obtained over the 13 first patients. Then, additional 16 eligible patients will be accrued up to 29 patients. If at least 8 patients show response, further investigation of this scheme is warranted. Taking into account that 10% of enrolled patients might not be evaluable (losses), an extra amount of 3 patients may be recruited per cohort.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Universitari Vall d'Hebrón, Barcelona, Cataluña, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain

Hospital General Universitario Gregorio Marañón, Madrid, Comunidad De Madrid, Spain

Hospital Clínico San Carlos, Madrid, Comunidad De Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz, Madrid, Comunidad De Madrid, Spain

Hospital Universitario La Paz, Madrid, Comunidad De Madrid, Spain

Hospital Universitario de Canarias, Tenerife, Islas Canarias, Spain

Contact Details

Name: Andrés Redondo

Affiliation: Hospital Universitario La Paz

Role: PRINCIPAL_INVESTIGATOR

Name: Claudia Valverde

Affiliation: Hospital Universitari Vall d'Hebrón

Role: PRINCIPAL_INVESTIGATOR

Name: Katarina Majercakova

Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Role: PRINCIPAL_INVESTIGATOR

Name: Josefina Cruz

Affiliation: Hospital Universitario de Canarias

Role: PRINCIPAL_INVESTIGATOR

Name: Rosa Álvarez

Affiliation: Hospital General Universitario Gregorio Marañón

Role: PRINCIPAL_INVESTIGATOR

Name: Antonio Casado

Affiliation: Hospital San Carlos, Madrid

Role: PRINCIPAL_INVESTIGATOR

Name: Javier Martín Broto

Affiliation: Hospital Universitario Fundación Jiménez Díaz

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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