Inoperable Esophageal Cancer Stage I-III Clinical Trial
Official title:
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
| Status | Recruiting |
| Enrollment | 108 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 - 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: - Subjects with distant metastases - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | The First People`s Hospital of Lianyungang | Lianyungang | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First People's Hospital of Lianyungang | Donghai People's Hospital, People's Hospital of Ganyu, The East Hospital of Lianyungang |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Overall survival | 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. | up to 2 years | Yes |
| Primary | Progression-Free-Survival | 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. | up to 2 years | Yes |
| Secondary | Response Rate | 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. | up to 2 years | Yes |