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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer; Induction Chemotherapy
• Intervention / Treatment: Drug: carboplatin paclitaxel

Detailed Description

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. The primary endpoint is to the evaluate the number of complete pathologic response. The secondary endpoints are evaluation of toxicity, radiologic response, metabolic response, results of the minimally invasive surgery (blood lost, number of conversion to open surgery, type of resection, R0, 1 or 2, post-op complications, time of hospitalization, 30 day post-op mortality), evaluate the viability of treatment protocol (number of patient that complete the phases), evaluate quality of life during the treatment and after the surgery. Inclusion criterias are: 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, neutrophils count > 1500/mm3, platelets count > 100.000/mm3, hemoglobin count > 9 g/dL, preserve hepatic and renal function, stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0, signature of the informed consent. Exclusion criterias are: history of another cancer, except skin non melanoma, pregnancy or history of hypersensitivity to the study drugs

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mariana Siqueira, MD; Phone Number: +552132071024; Email: maribruno2003@yahoo.com.br
• Study Contact Backup: Name: Alessandra Marins; Phone Number: +552132076665; Email: amarins@inca.gov.br

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Recruiting
    • INCA- Instituto Nacional de Câncer
    • Contact: Alessandra Marins; Phone Number: 00552132076666
    • Contact: Andrea Roza; Email: aroza@inca.gov.br
    • Sub-Investigator: Juliana O Souza, MD
    • Principal Investigator: Luiz Henrique Araujo, MD, PhD
    • Principal Investigator: Siqueira B Mariana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of another cancer, except skin non melanoma
• Pregnancy
• History of hypersensitivity to the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: induction carboplatin paclitaxel; carboplatin 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	Drug: carboplatin paclitaxel; induction carboplatin paclitaxel for 2 cycles; Other Names: Taxol, Carbo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete pathological response	complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cancer, Brazil
• Investigators: Principal Investigator: Mariana Siqueira, MD, INCA Brazil

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: 54633416.3.0000.5274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No