Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer

Mona Frolova

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Carcinoma; Esophageal Neoplasms; Concurrent Chemoradiotherapy

Treatments: Drug: Paclitaxel; Drug: Cisplatin; Drug: Fluorouracil; Procedure: Ivor Lewis esophagogastrectomy; Radiation: chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03579004

2017-038

Details and patient eligibility

About

This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Trimodality approach

Experimental group

Description:

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.

Treatment:

Radiation: chemoradiotherapy

Drug: Fluorouracil

Procedure: Ivor Lewis esophagogastrectomy

Drug: Cisplatin

Drug: Paclitaxel