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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
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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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