Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma

NCT02969473 | Unknown Phase 2 DMC

• 1 other identifier: YP2010138
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Conditions

Esophageal Neoplasm; Chemoradiation

Keywords

esophageal squamous cell carcinoma; concurrent chemoradiotherapy; docetaxel; cisplatin; 5-fluorouracil

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  From the date of randomization until the date of death, up to 5 years.

Secondary Outcomes (3)

• Treatment response rate

  From the date of randomization until six weeks after treatment completion.

• Progress Free Survival (PFS)

  From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

• Acute treatment-related toxicities

  From the date of randomization until six months after treatment completion.

Study Arms (2)

PF group

ACTIVE COMPARATOR

This is the active comparator group. All patients in this group will receive concurrent chemoradiotherapy with PF regimen (5-fluorouracil plus cisplatin).

Drug: Fluorouracil

DP group

EXPERIMENTAL

This is the experimental group. All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).

Drug: Docetaxel

Interventions

Docetaxel DRUG

Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator. Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the DP group received two cycles of DP regimen (docetaxel 60 mg/m2 delivered on day 1 and cisplatin 80 mg/m2 delivered on day 1) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.

Also known as: cisplatin

DP group

Fluorouracil DRUG

Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator. Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the PF group received two cycles of PF regimen (cisplatin 80 mg/m2 delivered on day 1 and 5-FU 1000 mg/m2 continuous infusion over 24 hours daily on days 1-4) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.

Also known as: cisplatin

PF group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with histologically proven squamous cell carcinoma of the esophagus
• stage II-IVA disease, including metastatic celiac or cervical nodes, according to the sixth edition of American Joint Committee on Cancer (AJCC) staging system for esophageal cancer
• aged between 18 and 70 years
• Karnofsky Performance Status (KPS) score ≥ 70
• adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥ 100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and serum aspartate aminotransferase (AST) level \< twice the upper limit of normal, and serum bilirubin level of \<1.5 mg/dL), and adequate renal function (creatinine clearance ≥ 50 mL/min)
• no other serious medical conditions
• life expectancy ≥ 3 months
• written informed consent

You may not qualify if:

• detection of distant metastasis (excluding metastatic celiac or cervical nodes) before treatment before treatment
• known allergy to CDDP, 5-FU, or docetaxel
• pregnancy or breast feeding

Sponsors & Collaborators

• Zhu Yujia: lead

Study Sites (1)

SYSU Cancer Center

Guangzhou, Guangdong, 510000, China

Location

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MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; 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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yonghong Hu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 21, 2016
• Study Start: October 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

CN (1)