Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma
Prospective, Non-randomised Phase Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Locally Advanced Esophageal Carcinoma
1 other identifier
interventional
120
1 country
1
Brief Summary
This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2016
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
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 30, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJuly 26, 2019
July 1, 2019
3.4 years
July 30, 2016
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pathological response rate
Up to 1 year
Pathological lymph node metastases rate
Up to 1 year
R0 resection rate
Up to 1 year
Adverse events
Up to 2 years
Secondary Outcomes (3)
Disease-free survival (DFS)
Up to 2 years
Overall survival (OS)
Up to 2 years
Recurrence rate
Up to 2 years
Study Arms (4)
Neoadjuvant nimotuzumab
EXPERIMENTALRadiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent nimotuzumab: Patients may receive nimotuzumab 400mg per week which start from 1 week before radiotherapy and in the following 4 weeks after enrollment in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
Neoadjuvant chemotherapy
ACTIVE COMPARATORRadiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent chemotherapy: Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks after enrollment in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
Radical nimotuzumab
EXPERIMENTALRadiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent nimotuzumab: Patients may receive nimotuzumab 400mg per week which start from 1 week before radiotherapy and in the following 4 weeks after enrollment in the absence of disease progression or unacceptable toxicity.
Radical chemotherapy
ACTIVE COMPARATORRadiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent chemotherapy: Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks after enrollment in the absence of disease progression or unacceptable toxicity.
Interventions
To achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively
nimotuzumab 400mg per week which start from 1 week before radiotherapy and in the following 4 weeks
Paclitaxel from 45 to 60 mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks
Nedaplatin 25mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks
Radical esophagectomy 4-6 weeks after neoadjuvant therapy
Eligibility Criteria
You may qualify if:
- Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma
- KPS≥70
- Adequate organ function
- No known history of drug allergy
You may not qualify if:
- Known drug allergy
- Insufficient hepatorenal function
- Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- Hebei Medical University Fourth Hospitalcollaborator
- Affiliated Hospital of Hebei Universitycollaborator
- Beijing Army General Hospitalcollaborator
- Beijing Hospitalcollaborator
- Peking University First Hospitalcollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Henan Cancer Hospitalcollaborator
- The Affiliated Hospital of Inner Mongolia Medical Universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Fujian Cancer Hospitalcollaborator
Study Sites (1)
Zefen Xiao
Beijing, Beijing Municipality, 100021, China
Related Publications (6)
Ajani JA, D'Amico TA, Almhanna K, Bentrem DJ, Besh S, Chao J, Das P, Denlinger C, Fanta P, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hochwald S, Hofstetter WL, Ilson DH, Jaroszewski D, Jasperson K, Keswani RN, Kleinberg LR, Korn WM, Leong S, Lockhart AC, Mulcahy MF, Orringer MB, Posey JA, Poultsides GA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Washington MK, Willett CG, Wright CD, Zelman D, McMillian N, Sundar H; National comprehensive cancer network. Esophageal and esophagogastric junction cancers, version 1.2015. J Natl Compr Canc Netw. 2015 Feb;13(2):194-227. doi: 10.6004/jnccn.2015.0028.
PMID: 25691612RESULTvan Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
PMID: 22646630RESULTSjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.
PMID: 21684205RESULTKranzfelder M, Schuster T, Geinitz H, Friess H, Buchler P. Meta-analysis of neoadjuvant treatment modalities and definitive non-surgical therapy for oesophageal squamous cell cancer. Br J Surg. 2011 Jun;98(6):768-83. doi: 10.1002/bjs.7455. Epub 2011 Apr 4.
PMID: 21462364RESULTHarari PM, Huang SM. Combining EGFR inhibitors with radiation or chemotherapy: will preclinical studies predict clinical results? Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):976-83. doi: 10.1016/j.ijrobp.2003.09.097.
PMID: 14967459RESULTRamos-Suzarte M, Lorenzo-Luaces P, Lazo NG, Perez ML, Soriano JL, Gonzalez CE, Hernadez IM, Albuerne YA, Moreno BP, Alvarez ES, Callejo IP, Alert J, Martell JA, Gonzalez YS, Gonzalez YS, Astudillo de la Vega H, Ruiz-Garcia EB, Ramos TC. Treatment of malignant, non-resectable, epithelial origin esophageal tumours with the humanized anti-epidermal growth factor antibody nimotuzumab combined with radiation therapy and chemotherapy. Cancer Biol Ther. 2012 Jun;13(8):600-5. doi: 10.4161/cbt.19849. Epub 2012 Jun 1.
PMID: 22555809RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2016
First Posted
August 8, 2016
Study Start
June 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2021
Last Updated
July 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share