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Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer

NCT02924909 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-03-20

No results posted yet for this study

Summary

Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.

Conditions

  • Esophageal Cancer
  • Induction Chemotherapy

Interventions

DRUG

carboplatin paclitaxel

induction carboplatin paclitaxel for 2 cycles

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Mariana Siqueira, MD · INCA Brazil

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Brazil

Study Locations

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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 NCT02924909 on ClinicalTrials.gov