A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
NCT ID: NCT01732380
Last Updated: 2012-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
108 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Radiotherapy
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Raltitrexed
Oxaliplatin
Radiotherapy
Interventions
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Raltitrexed
Oxaliplatin
Radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease according to RECIST criteria
* Age \> 18 years
* WHO performance score \< 2
* Estimated life expectancy of \> 12 weeks
* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
* Renal function: Cr ≤ 1.25×UNL
* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
* Documented informed consent to participate in the trial
Exclusion Criteria
* Pregnancy or breast feeding. Women of childbearing age must use effective contraception
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Evidence of bleeding diathesis or serious infection
* pregnant or lactating woman
* Patient participation in other studies
18 Years
80 Years
ALL
No
Sponsors
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The East Hospital of Lianyungang
UNKNOWN
Donghai People's Hospital
OTHER
People's Hospital of Ganyu
OTHER
The First People's Hospital of Lianyungang
OTHER
Responsible Party
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Principal Investigators
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Xiaodong Jiang, Doctor
Role: STUDY_CHAIR
The First People's Hospital of Lianyungang
Locations
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The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Xiaodong Jiang, Doctor
Role: primary
References
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Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.
Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.
McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.
Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.
Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
Other Identifiers
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1stPeopleLianyungang
Identifier Type: -
Identifier Source: org_study_id