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RANDOMIZED STUDY OF PHASE III OF CARBOPLATIN, PACLITAXEL AND THORAXIC RADIOTHERAPY WITH OR WITHOUT TALIDOMIDE IN PATIENTS WITH CLINICAL STAGE III NSCLC

RANDOMIZED STUDY OF PHASE III OF CARBOPLATIN, PACLITAXEL AND THORAXIC RADIOTHERAPY WITH OR WITHOUT TALIDOMIDE IN PATIENTS WITH CLINICAL STAGE III NSCLC

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-104-03
Enrollment
Unknown
Registered
2004-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Placlitaxel / Carboplatin Type of group
PACLITAXEL: 225 mg / m (infusion E.V. in 3 hours) day 1. CARBOPLATIN: AUC = 6 (infusion E.V. 15-30 min.) Immediately after Paclitaxel, day 1. Each patient receives 2 cycles (2nd cycle begins day 22). Group name:PACLITAXEL / CARBOPLATIN / TALIDOMIDE Type of group
PACLITAXEL: 225 mg / m2 (infusion of E.V. in 3 hours) day 1. CARBOPLATINUM: AUC = 6 (infusion E.V. 15-30 min.) Immediately after Paclitaxel, day 1. Each patient receives 2 cycles, 2 cycle begins day 22. TALIDOMIDE: Daily dose starting day 1, up to 24 months. Initial dose 200 mg
see protocol for escalar dose.

Sponsors

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed histological and confirmed non-small cell bronchogenic carcinoma. Patients must have either unresectable Stage MIA disease or Stage MIB disease without significant pleural effusion. Unresectable.

Exclusion criteria

Exclusion criteria: Los pacientes no deben estar embarazadas o amamantando debido a los conocidos efectos teratogenicos de la Thaidomida. Las pacientes femeninas que tienen alguna posibilidad de quedar embarazadas deben tener un prueba de embarazo realizada dentro de las 24 horas del comienzo de la thaidomida, semanalmente durante las primeras 4 semanas de tratamiento, y luego cada 4 semanas si los periodos de los pacientes son regulares o cada 2 semanas si no lo son. Las mujeres en edad fertil y los varones sexualmente activos deben usar dos metodos anticonceptivos aceptados y efectivos.

Design outcomes

Primary

MeasureTime frame
Outcome name:time of life Measure:survival and time to progression of patients with stage IIIA or IIIB NSCLC, receiving induction chemotherapy and concurrent chemoradiotherapy with or without thalidomide. Timepoints:6 meses—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)