Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

NCT00400114

Last updated date
Study Location
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Esophageal CancerSutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
NCT00400114
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  2. Toronto, Ontario
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Advanced Information
Descriptive Information
Brief Title  ICMJE Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
Official Title  ICMJE Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Drug: Irinotecan
    Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
  • Drug: Cisplatin
    Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
  • Procedure: Radiation
    Radiation 50 Gy (weeks 4-9)
  • Procedure: Surgery
    Esophagectomy
  • Drug: sunitinib (Sutent)
    sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.
Study Arms  ICMJE Experimental: sunitinib
Interventions:
  • Drug: Irinotecan
  • Drug: Cisplatin
  • Procedure: Radiation
  • Procedure: Surgery
  • Drug: sunitinib (Sutent)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2006)
36
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 19, 2016
Actual Primary Completion Date September 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00400114
Other Study ID Numbers  ICMJE 06-0407-C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jennifer J Knox, MD M.Sc. FRCPCUniversity Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP