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

July 4, 2018 updated by: Mona Frolova

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexey Tryakin, MD, PhD
  • Phone Number: +7 4993249259
  • Email: atryakin@mail.ru

Study Contact Backup

  • Name: Ilya Pokataev, MD, PhD
  • Phone Number: +7 4993241219
  • Email: pokia@mail.ru

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Recruiting
        • Alexey Tryakin
        • Contact:
      • Moscow, Russian Federation, 115478
        • Recruiting
        • Russian Cancer Research Center named after N.N.Blokhin RAMS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexey Tryakin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Paclitaxel
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Other Names:
  • chemotherapy
Drug: Cisplatin
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Other Names:
  • chemotherapy
Drug: Fluorouracil
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
Other Names:
  • chemotherapy
Radiation: chemoradiotherapy
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
Other Names:
  • chemoradiation
Procedure: Ivor Lewis esophagogastrectomy
Open Ivor Lewis esophagogastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mona Frolova

Investigators

  • Principal Investigator: Alexey Tryakin, MD, PhD, N.N.Blokhin Russian Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Anticipated)

July 10, 2020

Study Completion (Anticipated)

July 10, 2020

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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