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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.
Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunitinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer. | 5 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of adjuvant targeted therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III, and to compare these data to our current completed trial in the same patient population | 5 yrs | |
| To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer J Knox, MD M.Sc. FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada | ||
| University Health Network (Princess Margaret & Toronto General Hospitals) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26663741 | Background | Horgan AM, Darling G, Wong R, Guindi M, Liu G, Jonker DJ, Lister J, Xu W, MacKay HM, Dinniwell R, Kim J, Pierre A, Shargall Y, Asmis TR, Agboola O, Seely AJ, Ringash J, Wells J, Marginean EC, Haider M, Knox JJ. Adjuvant sunitinib following chemoradiotherapy and surgery for locally advanced esophageal cancer: a phase II trial. Dis Esophagus. 2016 Nov;29(8):1152-1158. doi: 10.1111/dote.12444. Epub 2015 Dec 10. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D002945 | Cisplatin |
| D011827 | Radiation |
| D013514 | Surgical Procedures, Operative |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
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| Cisplatin |
| Drug |
Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8 |
|
| Radiation | Procedure | Radiation 50 Gy (weeks 4-9) |
|
| Surgery | Procedure | Esophagectomy |
|
| sunitinib (Sutent) | Drug | sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op. |
|
| 2 yrs |
| To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease | 5 yrs |
| Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol | 5 yrs |
| To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy | 5 yrs |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007287 |
| Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |