Concurrent Chemoradiotherapy, Esophageal Neoplasms, Squamous Cell Carcinoma
Conditions
Keywords
esophageal squamous cell carcinoma, preoperative chemoradiotherapy, preoperative chemotherapy
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.
Interventions
DRUGPaclitaxel
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
DRUGCisplatin
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
DRUGFluorouracil
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
RADIATIONchemoradiotherapy
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
PROCEDUREIvor Lewis esophagogastrectomy
Open Ivor Lewis esophagogastrectomy
Sponsors
Mona Frolova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-75 2. 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 3. No prior antineoplastic treatment 4. Eastern Cooperative Oncology Group (ECOG) status 0-2 5. 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 * bilirubin \> 1,5 х ULN 6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment 7. Patients must follow appropriate contraception rules during whole treatment period 8. Decrease of body weight must not be more than 20% in last 6 months
Exclusion criteria
1. Presence of distant metastases except for metastatic supraclavicular lymphnodes; 2. Bulky (\>3 cm) regional lymphnodes metastases; 3. Cervical esophageal cancer; 4. Presence of tumor fistula; 5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer; 6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 24 months | Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | Overall survival will be calculated from the start of the treatment to the death of any reason. |
| Objective response rate according to RECIST 1.1 | 24 months | Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy. |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 24 months | Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0 |
| Pathological complete response rate following chemoradiotherapy | 24 months | Pathological complete response rate following chemoradiotherapy will be assessed in resected patients |
Countries
Russia
Contacts
Primary ContactAlexey Tryakin, MD, PhD
Backup ContactIlya Pokataev, MD, PhD
Outcome results
None listed