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

• ClinicalTrials.gov Identifier: NCT00686114
• Recruitment Status: Unknown
• First Posted: May 29, 2008
• Last Update Posted: April 29, 2014
• Sponsor: Wenzhou Medical University
• Information provided by (Responsible Party): Wu Shixiu, Wenzhou Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer	Drug: Paclitaxel; Drug: Cisplatin; Drug: Tarceva; Radiation: Radiotherapy	Phase 3

Detailed Description:

For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 344 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
• Study Start Date: May 2008
• Estimated Primary Completion Date: December 2014
• Estimated Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Enlarged field + Paclitaxel + Cisplatin + Tarceva	Drug: Paclitaxel; 135mg/m2, day 1 and day 29 of the radiotherapy.; Drug: Cisplatin; 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.; Drug: Tarceva; 150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy); Other Name: Erlotinib Hydrochloride Tablets; Radiation: Radiotherapy; Enlarged field radiotherapy
Experimental: B; Enlarged field + Paclitaxel + Cisplatin	Drug: Paclitaxel; 135mg/m2, day 1 and day 29 of the radiotherapy.; Drug: Cisplatin; 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.; Radiation: Radiotherapy; Enlarged field radiotherapy
Active Comparator: C; Conventional field + Paclitaxel + Cisplatin + Tarceva	Drug: Paclitaxel; 135mg/m2, day 1 and day 29 of the radiotherapy.; Drug: Cisplatin; 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.; Drug: Tarceva; 150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy); Other Name: Erlotinib Hydrochloride Tablets; Radiation: Radiotherapy; Conventional field radiotherapy
Active Comparator: D; Conventional field + Paclitaxel + Cisplatin	Drug: Paclitaxel; 135mg/m2, day 1 and day 29 of the radiotherapy.; Drug: Cisplatin; 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.; Radiation: Radiotherapy; Conventional field radiotherapy

Outcome Measures

Primary Outcome Measures :

1. overall survival [ Time Frame: five years after enrollment ]
   failure: death from any cause

Secondary Outcome Measures :

1. Progression-free survival [ Time Frame: five years after enrollment ]
   Failure: occurrence of local or regional progression, distant metastases, or death from any cause
2. local-regional control rate [ Time Frame: three years after enrollment ]
   Failure: occurrence of local or regional progression
3. Adverse events [ Time Frame: five years after enrollment ]
   assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
4. Health-related quality of life [ Time Frame: five years after enrollment ]
   assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects must be confirmed Esophageal Carcinoma pathologically
2. (EUS)I～IVa, without contraindication for radical radiotherapy
3. Subjects haven't been given neither radiotherapy nor chemotherapy before
4. Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
5. 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
6. Subjects should sign for the informed consent
7. Subjects should perform good compliance
8. Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
3. 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
4. Patients who multiple foci esophagus
5. Patients who are/were given any other medicine tests currently/in last 4 weeks
6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
7. Women in status of pregnancy
8. 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

Contacts and Locations

Contacts

Contact: Shixiu Wu, MD; 86-0577-8806-9372; wushixiu@medmail.com.cn

Locations

China, Zhejiang

1st affliated hospital of Wen Zhou Medical college; Recruiting

Wen Zhou, Zhejiang, China, 325000

Contact: Shixiu Wu, M.D. +86057788069372 wushixiu@medmail.com.cn

Contact: Xuebang Zhang, M.D. baxuza@126.com

Principal Investigator: Shixiu Wu, MD

Sponsors and Collaborators

Wenzhou Medical University

Investigators

• Principal Investigator: Shixiu Wu, MD; 1st affliated hospital of Wen Zhou Medical college

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wu Shixiu, Professor, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT00686114
• Other Study ID Numbers: Shixiu - 1
• First Posted: May 29, 2008
• Last Update Posted: April 29, 2014
• Last Verified: April 2014

Keywords provided by Wu Shixiu, Wenzhou Medical University:

Esophageal cancer; chemoradiation; radiosensitivity; EGFR inhibition

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Paclitaxel; Erlotinib Hydrochloride; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Tyrosine Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors