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

Primary Purpose

Esophageal Neoplasms, Squamous Cell Carcinoma, Concurrent Chemoradiotherapy

Status

Unknown status

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Paclitaxel

Cisplatin

Fluorouracil

chemoradiotherapy

Ivor Lewis esophagogastrectomy

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring esophageal squamous cell carcinoma, preoperative chemoradiotherapy, preoperative chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18-75
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
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

Exclusion Criteria:

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;

Sites / Locations

Alexey TryakinRecruiting
Russian Cancer Research Center named after N.N.Blokhin RAMSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trimodality approach

Arm 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.

Outcomes

Primary Outcome Measures

Disease free survival

Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.

Secondary Outcome Measures

Overall survival

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

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

Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0

Pathological complete response rate following chemoradiotherapy

Pathological complete response rate following chemoradiotherapy will be assessed in resected patients

Full Information

NCT ID

NCT03579004

First Posted

June 12, 2018

Last Updated

July 4, 2018

Sponsor

Mona Frolova

1. Study Identification

Unique Protocol Identification Number

NCT03579004

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 10, 2017 (Actual)

Primary Completion Date

July 10, 2020 (Anticipated)

Study Completion Date

July 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mona Frolova

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms, Squamous Cell Carcinoma, Concurrent Chemoradiotherapy

Keywords

esophageal squamous cell carcinoma, preoperative chemoradiotherapy, preoperative chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trimodality approach

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Other Intervention Name(s)

chemotherapy

Intervention Description

Fluorouracil is used in two cycles of neoadjuvant chemotherapy

Intervention Type

Radiation

Intervention Name(s)

chemoradiotherapy

Other Intervention Name(s)

chemoradiation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Ivor Lewis esophagogastrectomy

Intervention Description

Open Ivor Lewis esophagogastrectomy

Primary Outcome Measure Information:

Title

Disease free survival

Description

Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival will be calculated from the start of the treatment to the death of any reason.

Time Frame

24 months

Title

Objective response rate according to RECIST 1.1

Description

Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.

Time Frame

24 months

Title

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

Description

Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0

Time Frame

24 months

Title

Pathological complete response rate following chemoradiotherapy

Description

Pathological complete response rate following chemoradiotherapy will be assessed in resected patients

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-75 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 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 Exclusion Criteria: 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexey Tryakin, MD, PhD

Phone

4993249259

Ext

atryakin@mail.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Ilya Pokataev, MD, PhD

Phone

4993241219

Ext

pokia@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexey Tryakin, MD, PhD

Organizational Affiliation

N.N.Blokhin Russian Cancer Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexey Tryakin

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexey Tryakin, MD, PhD

Phone

4993249259

Ext

atryakin@mail.ru

Facility Name

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

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexey Tryakin, PhD

Phone

+74993249259

atryakin@mail.ru

First Name & Middle Initial & Last Name & Degree

Ilya Pokataev

Phone

+74993241219

pokia@mail.ru

First Name & Middle Initial & Last Name & Degree

Alexey Tryakin, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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