Study Stopped
Because there are questions about adjuvant radiotherapy in this study, the clinical trial is under re-design.
Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line treatment in unresectable or metastatic ESCC. The results showed that the overall response rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of 24 months, the median progression-free survival for patients with metastatic disease and local advanced disease were 8.2 months and more than 23 months respectively. The overall survival for patients with metastatic disease was 13.9 months. It implied that as first-line chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option compared to other regimens published in previous studies. Investigations by Liang, J. and Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also showed anti-tumor activities and limited toxicities. Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could bring survival benefit for ESCC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 18, 2021
March 1, 2021
6.1 years
October 11, 2014
March 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first. An expected average of 2 years.
2 years
Secondary Outcomes (4)
Overall survival
3 years
Pathological complete response of neoadjuvant treatment
4 months
The R0 resection rate
3 months
Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria.
6 months
Study Arms (3)
Nimotuzumab with Chemotherapy
EXPERIMENTALPatients will receive neoadjuvant chemotherapy of paclitaxel and cisplatin with concurrent nimotuzumab. Paclitaxel 175mg per square metre on day 1 and cisplatin 30mg per square metre on day 1 and day 2 every 3 weeks for 2 cycles. Nimotuzumab 200mg per week for 6 weeks. After neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
Nimotuzumab with radiotherapy
EXPERIMENTALPatients will receive neoadjuvant radiotherapy with concurrent nimotuzumab. Intensity-modulated radiation therapy(IMRT) of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks. After neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
Surgery alone
ACTIVE COMPARATORPatients in this group will be given esophagectomy without any neoadjuvant treatment. Adjuvant radiotherapy is permit for patients with positive lymph nodes metastasis.
Interventions
Nimotuzumab 200mg per week for 6 weeks.
Paclitaxel 175mg per square metre on day 1, repeated every 3 weeks for 2 cycles.
Cisplatin 30mg per square metre on day 1 and day 2, repeated every 3 weeks for 2 cycles.
IMRT of primary tumor and local lymph nodes with 95% PTV of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks.
Eligibility Criteria
You may qualify if:
- Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
- Weight loss must be less than 10% in last 6 months.
- With an expected life expectancy of ≥ 12 months
- With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
- With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
- With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Without serious system dysfunction and could tolerate chemotherapy or radiotherapy.
- Patients must have normal marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
- Patients must have normal electrocardiogram results and no history of congestive heart failure.
- Women of childbearing age should voluntarily take contraceptive measures.
- Without drug addition
- Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.
You may not qualify if:
- Allergic to known drug
- Patients who have received prior treatment including chemotherapy, radiotherapy and surgery.
- With unresectable disease including any T4b or M1 disease.
- Without measurable or evaluable disease.
- With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
- With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
- With neurological or psychiatric abnormalities that affect cognitive.
- Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital & Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaodong Zhang, M.D.
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the VIP-II Gastrointestinal Oncology Division of Medical Department
Study Record Dates
First Submitted
October 11, 2014
First Posted
October 23, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
March 18, 2021
Record last verified: 2021-03