A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

NCT02915965 | Unknown Phase 2

• 1 other identifier: ESCC01-SUMS6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Conditions

Stage II and III Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall survival rate

  2 years

Secondary Outcomes (3)

• Pathologic response rate

  2 years

• Disease-free survival

  2 years

• Incidence of adverse event based on CTCAE 4.0

  2 years

Study Arms (1)

DCX and surgery

EXPERIMENTAL

docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy

Drug: DCX; Procedure: surgery

Interventions

DCX DRUG

docetaxel, cisplatin and capecitabine

DCX and surgery

surgery PROCEDURE

Ivor Lewis Esophagectomy

DCX and surgery

Eligibility Criteria

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

You may qualify if:

• Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
• Patients must not have received any prior anticancer therapy.
• More than 6 months of expected survival.
• Age ranges from 18 to 70 years.
• Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
• Karnofsky performance status (KPS) of 90 or more.
• Signed informed consent document on file.

You may not qualify if:

• Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
• Patients with concomitant hemorrhagic disease.
• Pregnant or breast feeding.
• Inability to use gastric conduit after esophagectomy because of a prior surgery.
• Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
• Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Yanhong Deng, MD PHD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhong Deng, MD PHD

CONTACT

+86020 38379762; dengyanh@mail.sysu.edu.cn

Jiayu Ling, MD

CONTACT

+86020 38379762; lingjiay@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CN (1)