Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer
QUIMERA
Phase II Trial of Induction Chemotherapy Followed by Chemoradiotherapy With Paclitaxel and Carboplatin Before Minimal Invasive Surgery in Patients With Localized Esophageal and Gastro-esophageal Junction Cancer
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 20, 2018
March 1, 2018
3.6 years
August 31, 2016
March 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
complete pathological response
complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment
2 weeks after surgery
Study Arms (1)
induction carboplatin paclitaxel
EXPERIMENTALcarboplatin AUC=6 21 day cycle for 2 cycles paclitaxel 175 mg/m2 21 day cycle for 2 cycles radiotherapy 4500 cGy in 25 fractions carboplatin AUC=2 in a week regimen during radiotherapy paclitaxel 50 mg/m2 in a week regimen during radiotherapy Minimal Invasive Surgery
Interventions
induction carboplatin paclitaxel for 2 cycles
Eligibility Criteria
You may qualify if:
- Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II)
- Age between 18 and 75 years
- Performance Status 0 or 1
- Stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0
You may not qualify if:
- History of another cancer, except skin non melanoma
- Pregnancy
- History of hypersensitivity to the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INCA- Instituto Nacional de Câncer
Rio de Janeiro, 20231-050, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariana Siqueira, MD
INCA Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 31, 2016
First Posted
October 5, 2016
Study Start
February 1, 2017
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
March 20, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share