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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02924909
Other study ID # 54633416.3.0000.5274
Secondary ID
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
Health authority
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

Study Design


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
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