Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

NCT00686114 | Unknown Phase 3 DMC

• 1 other identifier: Shixiu - 1
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

Conditions

Esophageal Cancer

Keywords

Esophageal cancer; chemoradiation; radiosensitivity; EGFR inhibition

Outcome Measures

Primary Outcomes (1)

• overall survival

  failure: death from any cause

  five years after enrollment

Secondary Outcomes (4)

• Progression-free survival

  five years after enrollment

• local-regional control rate

  three years after enrollment

• Adverse events

  five years after enrollment

• Health-related quality of life

  five years after enrollment

Study Arms (4)

A

EXPERIMENTAL

Enlarged field + Paclitaxel + Cisplatin + Tarceva

Drug: Paclitaxel; Drug: Cisplatin; Drug: Tarceva; Radiation: Radiotherapy

B

EXPERIMENTAL

Enlarged field + Paclitaxel + Cisplatin

Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

C

ACTIVE COMPARATOR

Conventional field + Paclitaxel + Cisplatin + Tarceva

Drug: Paclitaxel; Drug: Cisplatin; Drug: Tarceva; Radiation: Radiotherapy

D

ACTIVE COMPARATOR

Conventional field + Paclitaxel + Cisplatin

Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Paclitaxel DRUG

135mg/m2, day 1 and day 29 of the radiotherapy.

A; B; C; D

Cisplatin DRUG

20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.

A; B; C; D

Tarceva DRUG

150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)

Also known as: Erlotinib Hydrochloride Tablets

A; C

Radiotherapy RADIATION

Enlarged field radiotherapy

A; B

Eligibility Criteria

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

You may qualify if:

• Subjects must be confirmed Esophageal Carcinoma pathologically
• (EUS)I～IVa, without contraindication for radical radiotherapy
• Subjects haven't been given neither radiotherapy nor chemotherapy before
• Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
• In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
• Subjects should sign for the informed consent
• Subjects should perform good compliance

You may not qualify if:

• Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
• Complete obstruction of the esophagus, or patients who have the potential to develop perforation
• Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
• Patients who multiple foci esophagus
• Patients who are/were given any other medicine tests currently/in last 4 weeks
• Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
• Women in status of pregnancy
• Patients who have complications exist as following:
• (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

1st affliated hospital of Wen Zhou Medical college

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (1)

• Xie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22.

  PMID: 32958820 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Cisplatin; Erlotinib Hydrochloride; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Shixiu Wu, MD

  1st affliated hospital of Wen Zhou Medical college

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shixiu Wu, MD

CONTACT

86-0577-8806-9372; wushixiu@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 29, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

CN (1)