Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell CarcinomaPhase 2NCT02123381
Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing preoperative radiotherapy and cetuximab in people with Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma
- What is being tested?
- preoperative radiotherapy and cetuximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
Who cannot join
- Patient who have distant metastasis
- The primary tumor or lymph node already received surgical treatment (except for biopsy);
- Patient who received radiotherapy for primary tumor or lymph node;
- Patient who received the the epidermal growth factor targeted therapy;
- Patient who received chemotherapy or immunotherapy;
- Patient who suffered from other malignant tumor;
Show all 13Show fewer
- Epidermal growth factor receptor（EGFR）mutation（-）;
- Patient who have taken other drug test within 1 month;
- Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
- Subject with a severe allergic history or idiosyncratic;
- Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
- Drug abuse or alcohol addicted;
- Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
TAO LI, MD, PhD, 86-18908178818, litaoxmf@163.com
About this study
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
This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.
- Being tested
- preoperative radiotherapy, cetuximab
- Keywords
- tumor tissue and serum biomarkers, cetuximab, preoperative radiotherapy, esophageal squamous cell carcinoma
- Medical subject headings
- Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative radiotherapyRadiation
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.
cetuximabDrug
Also called Erbitux, C225
400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Radiation: preoperative radiotherapy; Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after 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.
Measured: before radiotherapy and 1 months after the radiotherapy
Expression of p53 in Esophageal Squamous Cell Carcinoma before and after 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.
Measured: before radiotherapy and 1 months after the radiotherapy
changes of serum vascular endothelial growth factor（VEGF）level before and after radiotherapy
Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis.
Measured: before radiotherapy and 1 months after the radiotherapy
Secondary outcomes (6)
Quality of life (QOL)
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30）
Measured: up to 3 years
Overall survival
time from randomization to death
Measured: up to 3 years
PFS（progression-free survival）
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
Measured: up to 3 years
local control rate（LCR）
Time to locoregional failure after R0 resection
Measured: up to 3 years
Pathological remission
Measured: 1 months after the end of surgery
grade 3-5 adverse events
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Southwest Hospital, China, Xinqiao Hospital of Chongqing
- Responsible party
- Principal investigator, LI TAO, Sichuan Cancer Hospital and Research Institute
- Investigators
- YONGTAO HAN, MD, PhD, Principal investigator, Sichuan Cancer Hospital and Research InstituteGE WANG, MD, PhD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityTAIQIAN GONG, MD, PhD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityLONG CHEN, MD, PhD, Principal investigator, Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityNAIQUAN MAO, MD, PhD, Principal investigator, Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityZHIHUA RUAN, MD, PhD, Principal investigator, Southwest Hospital, ChinaGANG XIONG, MD, PhD, Principal investigator, Southwest Hospital, ChinaJIANGUO SUN, MD, PhD, Principal investigator, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123381
- Sponsor's protocol ID
- scch2014019
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02123381
- Acronym / sponsor ID
- scch2014019
- Keywords
- tumor tissue and serum biomarkers, cetuximab, preoperative radiotherapy, esophageal squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Southwest Hospital, China, Xinqiao Hospital of Chongqing
- Study start
- Apr 2014
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Radiation: preoperative radiotherapy, Drug: cetuximabAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
Key exclusion criteria (13 listed)
- Patient who have distant metastasis
- The primary tumor or lymph node already received surgical treatment (except for biopsy);
- Patient who received radiotherapy for primary tumor or lymph node;
- Patient who received the the epidermal growth factor targeted therapy;
- Patient who received chemotherapy or immunotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative radiotherapyPatients 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. | Radiation | Arm A |
| cetuximabAlso: Erbitux, C225400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4 | Drug | Arm A |
Primary outcome
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.
6 secondary outcomes
Quality of life (QOL)
Time frame: up to 3 years
Overall survival
Time frame: up to 3 years
PFS（progression-free survival）
Time frame: up to 3 years
local control rate（LCR）
Time frame: up to 3 years
Pathological remission
Time frame: 1 months after the end of surgery
grade 3-5 adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YONGTAO HAN, MD, PhD principal investigator
Sichuan Cancer Hospital and Research Institute
GE WANG, MD, PhD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
TAIQIAN GONG, MD, PhD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing preoperative radiotherapy and cetuximab in people with Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAO LI, MD, PhD (86-18908178818, litaoxmf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy (time frame: before radiotherapy and 1 months after the radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.