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Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

NCT01345084 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-03-28

No results posted yet for this study

Summary

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.

Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

Conditions

Interventions

RADIATION

Radiation Therapy

66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week

DRUG

Nimotuzumab

200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).

DRUG

Cisplatin

75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Gustavo Girotto · Hospital de Base São José do Rio Preto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-11-30
Completion
2017-11-30

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345084 on ClinicalTrials.gov