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

Squamous Cell Carcinoma Clinical Trial

Official title:

Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579004
• Other study ID #: 2017-038
• Status: Recruiting
• Phase: Phase 2
• Start date: July 10, 2017
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2018
• Source: Russian Academy of Medical Sciences
• Contact: Alexey Tryakin, MD, PhD
• Phone: 4993249259
• Email: atryakin[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?109/l

• thrombocytes = 100 ? 109/l

• hemoglobin = 90 mg/l

• creatinine < 115 µmol/? 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 ? 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;

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Concurrent Chemoradiotherapy
• Esophageal Neoplasms
• Squamous Cell Carcinoma

Intervention

Drug:
• Paclitaxel
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
• Cisplatin
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
• Fluorouracil
Fluorouracil is used in two cycles of neoadjuvant chemotherapy

Radiation:
• chemoradiotherapy
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.

Procedure:
• Ivor Lewis esophagogastrectomy
Open Ivor Lewis esophagogastrectomy

Locations

Country	Name	City	State
Russian Federation	Alexey Tryakin	Moscow
Russian Federation	Russian Cancer Research Center named after N.N.Blokhin RAMS	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Mona Frolova

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.	24 months
Secondary	Overall survival	Overall survival will be calculated from the start of the treatment to the death of any reason.	24 months
Secondary	Objective response rate according to RECIST 1.1	Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.	24 months
Secondary	Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0	24 months
Secondary	Pathological complete response rate following chemoradiotherapy	Pathological complete response rate following chemoradiotherapy will be assessed in resected patients	24 months