Clinical trial · Interventional
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)
NCT00400114CI-TRIAL-00027412completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiation | Procedure | — | UNRESOLVED |
| sunitinib (Sutent) | Drug | Sunitinib | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sunitinib
- interventionNames
- Drug: Irinotecan
- Drug: Cisplatin
- Procedure: Radiation
- Procedure: Surgery
- Drug: sunitinib (Sutent)
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 5 yrs
Secondary outcomes (5)
- measure
- 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
- timeFrame
- 5 yrs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including GE junction tumors (unless of gastric origin). * Tumors must be technically resectable. * Clinical T1N1M0, T2-3 N0-1 M0 * Performance status ECOG 0-1 * Medically fit for chemotherapy, radiation and esophagectomy Exclusion Criteria: * In situ or clinical T1N0M0, and stage IV (M1a orM1b) * Cervical esophageal tumors (within 20 cm of the incisors) * Age \<18 or \>70 * Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy * known or suspected drug or alcohol abuse * Prior treatment for this malignancy except esophageal stenting
References
Publications (1)
- BACKGROUNDHorgan 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. PMID 26663741