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

NCT03579004 | Unknown Phase 2

• 1 other identifier: 2017-038
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Conditions

Esophageal Neoplasms; Squamous Cell Carcinoma; Concurrent Chemoradiotherapy

Keywords

esophageal squamous cell carcinoma; preoperative chemoradiotherapy; preoperative chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  24 months

• Objective response rate according to RECIST 1.1

  24 months

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  24 months

• Pathological complete response rate following chemoradiotherapy

  24 months

Study Arms (1)

Trimodality approach

EXPERIMENTAL

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.

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

Interventions

Paclitaxel DRUG

Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy

Also known as: chemotherapy

Trimodality approach

Cisplatin DRUG

Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy

Also known as: chemotherapy

Trimodality approach

Fluorouracil DRUG

Fluorouracil is used in two cycles of neoadjuvant chemotherapy

Also known as: chemotherapy

Trimodality approach

chemoradiotherapy RADIATION

Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.

Also known as: chemoradiation

Trimodality approach

Ivor Lewis esophagogastrectomy PROCEDURE

Open Ivor Lewis esophagogastrectomy

Trimodality approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75
• 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
• bilirubin \> 1,5 х ULN
• Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
• Patients must follow appropriate contraception rules during whole treatment period
• Decrease of body weight must not be more than 20% in last 6 months

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mona Frolova: lead

Study Sites (2)

Alexey Tryakin

Moscow, 115478, Russia

RECRUITING

Russian Cancer Research Center named after N.N.Blokhin RAMS

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Drug Therapy; Cisplatin; Fluorouracil; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Radiotherapy

Study Officials

• Alexey Tryakin, MD, PhD

  N.N.Blokhin Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexey Tryakin, MD, PhD

CONTACT

4993249259; atryakin@mail.ru

Ilya Pokataev, MD, PhD

CONTACT

4993241219; pokia@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Staff Member

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 6, 2018
• Study Start: July 10, 2017
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

RU (2)