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Completed

NCT Number: NCT00400114

Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan

Drug

Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

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.

Primary outcomes

  1. 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.

    Time frame: 5 yrs

Secondary outcomes

  1. 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

    Time frame: 5 yrs

  2. To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III

    Time frame: 2 yrs

  3. To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease

    Time frame: 5 yrs

  4. Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol

    Time frame: 5 yrs

  5. To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy

    Time frame: 5 yrs

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2006
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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