Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer
- Registration Number
- NCT02924909
- Lead Sponsor
- Instituto Nacional de Cancer, Brazil
- 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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- History of another cancer, except skin non melanoma
- Pregnancy
- History of hypersensitivity to the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description induction carboplatin paclitaxel 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
- Primary Outcome Measures
Name Time Method complete pathological response 2 weeks after surgery complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
INCA- Instituto Nacional de Câncer
🇧🇷Rio de Janeiro, Brazil