A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Study Details
Study Description
Brief Summary
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Radiotherapy Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer |
Radiation: Radiotherapy
|
| Experimental: 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 |
Drug: Raltitrexed
Other Names:
Drug: Oxaliplatin
Other Names:
Radiation: Radiotherapy
|
Outcome Measures
Primary Outcome Measures
- Progression-Free-Survival [up to 2 years]
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
Secondary Outcome Measures
- Response Rate [up to 2 years]
Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.
Other Outcome Measures
- Overall survival [up to 2 years]
People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
-
Measurable disease according to RECIST criteria
-
Age > 18 years
-
WHO performance score < 2
-
Estimated life expectancy of > 12 weeks
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Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
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Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
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Renal function: Cr ≤ 1.25×UNL
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Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
-
Documented informed consent to participate in the trial
Exclusion Criteria:
-
Subjects with distant metastases
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | China | 222002 |
Sponsors and Collaborators
- The First People's Hospital of Lianyungang
- The East Hospital of Lianyungang
- Donghai People's Hospital
- People's Hospital of Ganyu
Investigators
- Study Chair: Xiaodong Jiang, Doctor, The First People's Hospital of Lianyungang
Study Documents (Full-Text)
None provided.More Information
Publications
- Cascinu S, Graziano F, Ferraù 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.
- 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. Review.
- 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.
- 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, François 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.
- 1stPeopleLianyungang