Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02123381|
Recruitment Status : Recruiting
First Posted : April 25, 2014
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma||Radiation: preoperative radiotherapy Drug: cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Middle or Lower Thoracic Esophageal Squamous Cell Carcinoma|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Arm A
All patients in the arm receive cetuximab combined with preoperative radiotherapy at first. 4-6 weeks after the rdiaotherapy，patients receive right thoracotomy with three incisions radical surgery.
Radiation: preoperative radiotherapy
Patients receive intensity modulated radiation therapy(IMRT) or image-guided radiation therapy(IGRT)from week 1 to week 4,once a day, 5 times per week.
Radiotherapy dose：95% gross tumor volume（GTV-T） 40Gy/20f，GTV-N 40Gy/20f，CTV-T 40Gy/20f，CTV-N 40Gy/20f.
400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4
- Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy [ Time Frame: before radiotherapy and 1 months after the radiotherapy ]Survivin, an inhibitor of apoptosis protein, is highly expressed in most cancers and associated with radiotherapy resistance, increased tumor recurrence, and shorter patient survival.
- Expression of p53 in Esophageal Squamous Cell Carcinoma before and after Radiotherapy [ Time Frame: before radiotherapy and 1 months after the radiotherapy ]p53 (also known as protein 53 or tumor protein 53), is a tumor suppressor protein that in humans is encoded by the TP53 gene.p53 is important in multicellular organisms and involved in preventing cancer.
- changes of serum vascular endothelial growth factor（VEGF）level before and after radiotherapy [ Time Frame: before radiotherapy and 1 months after the radiotherapy ]Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis.
- Quality of life (QOL) [ Time Frame: up to 3 years ]Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30）
- Overall survival [ Time Frame: up to 3 years ]time from randomization to death
- PFS（progression-free survival） [ Time Frame: up to 3 years ]
time from randomization to one of the following events, whichever comes first:
- Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions)
- Recurrence at local, regional or distant site after surgery
- Death from any cause
- local control rate（LCR） [ Time Frame: up to 3 years ]Time to locoregional failure after R0 resection
- Pathological remission [ Time Frame: 1 months after the end of surgery ]
- grade 3-5 adverse events [ Time Frame: up to 3 years ]Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0，such as esophagitis、pneumonitis and hematologic toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123381
|Contact: TAO LI, MD, PhDemail@example.com|
|Sichuan Cancer Hospital & Institute||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: TAO LI, MD, PhD 86-18908178818 firstname.lastname@example.org|
|Principal Investigator:||YONGTAO HAN, MD, PhD||Sichuan Cancer Hospital & Institute|
|Principal Investigator:||GE WANG, MD, PhD||Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|
|Principal Investigator:||TAIQIAN GONG, MD, PhD||Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|
|Principal Investigator:||LONG CHEN, MD, PhD||Affiliated Cancer Hospital & Institute of Guangzhou Medical University|
|Principal Investigator:||NAIQUAN MAO, MD, PhD||Affiliated Cancer Hospital & Institute of Guangzhou Medical University|
|Principal Investigator:||ZHIHUA RUAN, MD, PhD||Southwest Hospital, China|
|Principal Investigator:||GANG XIONG, MD, PhD||Southwest Hospital, China|
|Principal Investigator:||JIANGUO SUN, MD, PhD||Xinqiao Hospital of Chongqing|
|Principal Investigator:||GUANGHUI LI, MD.PHD||Xinqiao Hospital of Chongqing|
|Principal Investigator:||DEZHI LI, MD, PhD||Xinqiao Hospital of Chongqing|
|Principal Investigator:||MINGZHANG XIANG, MD,PhD||Xinqiao Hospital of Chongqing|