Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma
NCT ID: NCT00815308
Last Updated: 2011-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2009-01-31
2010-07-31
Brief Summary
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Detailed Description
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Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting.
Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer.
Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor (TGF)-α.
Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and radiation. For patients with locally advanced head and neck cancer, the combination of cetuximab and radiation has demonstrated both response and survival benefit.
With all these, the investigators hypothesize that treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation may further improve clinical outcomes. This trial results will be important as it may support further studies for setting the new treatment standard for ESCC.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cetuximab, concurrent chemo-radiotherapy
Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
cetuximab (Erbitux)
Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)
Paclitaxel
Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)
Cisplatin
Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)
Radiation
Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).
Interventions
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cetuximab (Erbitux)
Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)
Paclitaxel
Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)
Cisplatin
Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)
Radiation
Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)
* cervical esophageal carcinoma, stage Ⅱ-Ⅲ
* upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.
* Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).
* ECOG Performance status of 0-1
* Effective contraception for both male and female patients if the risk of conception exists
* Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
* Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
* Tumor tissue available for KRAS biomarker test
* Signed written informed consent prior to study entry
Exclusion Criteria
* Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
* Multiple primary carcinomas of the esophagus
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period;
* Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
* Unable to comprehend the study requirements or who are not likely to comply with the study parameters;
* Distant metastasis
* Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years
* Known grade 3 or 4 allergic reaction to any of the study treatment
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Peking University Cancer Hospital & Institute
OTHER
Hebei Fourth Hospital
UNKNOWN
Jiangsu Cancer Institute & Hospital
OTHER
RenJi Hospital
OTHER
The Affiliated Cancer Hospital of Zhengzhou University
UNKNOWN
West China Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Shandong Cancer Hospital and Institute
Principal Investigators
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Jin Ming Yu, PH.D, M.D
Role: STUDY_CHAIR
Shandong Cancer Hospital and Institute
Locations
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Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Countries
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References
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Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. doi: 10.1200/JCO.2001.19.2.305.
Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.
Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. doi: 10.1056/NEJM199707173370304.
Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702.
Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.
Raben D, Helfrich B, Bunn PA Jr. Targeted therapies for non-small-cell lung cancer: biology, rationale, and preclinical results from a radiation oncology perspective. Int J Radiat Oncol Biol Phys. 2004;59(2 Suppl):27-38. doi: 10.1016/j.ijrobp.2004.01.054.
Langer CJ. Emerging role of epidermal growth factor receptor inhibition in therapy for advanced malignancy: focus on NSCLC. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):991-1002. doi: 10.1016/j.ijrobp.2003.09.099.
Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.
Other Identifiers
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SDRTC-0901
Identifier Type: -
Identifier Source: org_study_id
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