Chemoradiotherapy in Elderly Patients With Oesophagus Cancer (OSAGE)
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|ClinicalTrials.gov Identifier: NCT02735057|
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : April 17, 2017
Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.
Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.
|Condition or disease||Intervention/treatment||Phase|
|Oesophagus Cancer Elderly Patients||Drug: Carboplatin||Phase 1 Phase 2|
Choice of the combined chemotherapy Carboplatin and taxanes delivered concurrently to radiotherapy is attractive. A Dutch randomized study (Cross trial) compared preoperative CRT to surgery in 368 patients with T1-T3 and N0N1. In the preoperative CRT group, patients received 41.4 Gy by EBRT over 5 weeks combined with carboplatin (AUC 2) and paclitaxel (50 mg/m2). A 30 % tumor sterilization rate and a reduction of metastasis considered a distant effect of chemotherapy were observed. The 5-year survival was statistically better with CRT group. The preoperative CRT was well tolerated and few acute toxicities were observed. Intriguingly, in a French randomized study, conducted in less locally advanced disease, the combination of 45 Gy and 5 FU infusion and Cisplatin did not induce more tumor sterilization rate, suggesting carboplatine/paclitaxel is more effective than 5FU/cisplatin in CRT.
Study design Since the optimal doses of each component radiotherapy- carboplatin - paclitaxel are unknown, we plan to conduct a phase I/II study
Phase I: the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II (RP2D) of each component considering the treatment scheme of Dutch study as reference:
- for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2)
- for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
- Phase II: after the determination of RP2D of each component, the study is continued as a phase II in order to assess tumor response Secondary objectives: Quality of life, progression free and overall survivals
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2024|
Experimental: Phase I
Other Name: Paclitaxel
- maximum tolerated dose (MTD) [ Time Frame: 1 months after the end of the treatment ]
the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II.The phase I is conducted with increasing doses of each component with 9 levels.Step definitively stopped in case of any grade ≥ 3 or severe acute toxicities. In case a step is definitively stopped, add 3 more patients to the precedent step.
- Quality of life [ Time Frame: 3 years ]EORTC QLQ-C30,
- Quality of life [ Time Frame: 3 years ]ELD14
- progression free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735057
|Contact: Stéphanie SERVAGI-VERNAT, Dremail@example.com|
|Centre Hospitalier Universitaire de Besançon||Recruiting|
|Besancon, France, 25000|
|Contact: Sophie DEPIERRE firstname.lastname@example.org|
|Principal Investigator: Gilles CREHANGE, PU-PH|
|Study Chair:||Sophie DEPIERRE||Centre Hospitalier Universitaire de Besançon|