Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Esophageal Neoplasms
- Sponsor
- Mona Frolova
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Disease free survival
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
Detailed Description
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma. Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.
Investigators
Mona Frolova
Senior Staff Member
Russian Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
- •No prior antineoplastic treatment
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
- •absolute neutrophil count ≥ 1,500 х109/l
- •thrombocytes ≥ 100 х 109/l
- •hemoglobin ≥ 90 mg/l
- •creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN)
- •alkaline phosphatase (ALP) \> 5 x ULN
Exclusion Criteria
- •Presence of distant metastases except for metastatic supraclavicular lymphnodes;
- •Bulky (\>3 cm) regional lymphnodes metastases;
- •Cervical esophageal cancer;
- •Presence of tumor fistula;
- •Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
- •Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
Arms & Interventions
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
Intervention: Paclitaxel
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
Intervention: Cisplatin
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
Intervention: Fluorouracil
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
Intervention: chemoradiotherapy
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
Intervention: Ivor Lewis esophagogastrectomy
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 24 months
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
Secondary Outcomes
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0(24 months)
- Objective response rate according to RECIST 1.1(24 months)
- Overall survival(24 months)
- Pathological complete response rate following chemoradiotherapy(24 months)