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

Esophageal Cancer Clinical Trial

— QUIMERA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02924909
• Other study ID #: 54633416.3.0000.5274
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2016
• Last updated: March 19, 2018
• Start date: February 1, 2017
• Est. completion date: September 2020

Study information

• Verified date: March 2018
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Mariana Siqueira, MD
• Phone: +552132071024
• Email: maribruno2003[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Induction Chemotherapy

Intervention

Drug:
• carboplatin paclitaxel
induction carboplatin paclitaxel for 2 cycles

Locations

Country	Name	City	State
Brazil	INCA- Instituto Nacional de Câncer	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete pathological response	complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment	2 weeks after surgery