Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400114
• Other study ID #: 06-0407-C
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2006
• Last updated: May 3, 2017
• Start date: September 25, 2006
• Est. completion date: September 19, 2016

Study information

• Verified date: May 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 19, 2016
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Irinotecan
Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
• Cisplatin
Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

Procedure:
• Radiation
Radiation 50 Gy (weeks 4-9)
• Surgery
Esophagectomy

Drug:
• sunitinib (Sutent)
sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	University Health Network (Princess Margaret & Toronto General Hospitals)	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III		2 yrs
Secondary	To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease		5 yrs
Secondary	Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol		5 yrs
Secondary	To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy		5 yrs