Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-25

Study Completion Date

2016-09-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer

NCT00160875

Esophageal Cancer

COMPLETED PHASE2/PHASE3

Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

NCT00316862

Esophageal Cancer

COMPLETED PHASE2

Combination Chemotherapy in Treating Patients With Esophageal Cancer

NCT00041262

Esophageal Cancer

UNKNOWN PHASE3

Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

NCT00165490

Adenocarcinoma of Esophagus Squamous Cell Carcinoma of Esophagus

COMPLETED PHASE2

A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma

NCT05370144

Esophageal Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sunitinib

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

Radiation

Intervention Type PROCEDURE

Radiation 50 Gy (weeks 4-9)

Surgery

Intervention Type PROCEDURE

Esophagectomy

sunitinib (Sutent)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Irinotecan

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

Intervention Type DRUG

Cisplatin

Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

Intervention Type DRUG

Radiation

Radiation 50 Gy (weeks 4-9)

Intervention Type PROCEDURE

Surgery

Esophagectomy

Intervention Type PROCEDURE

sunitinib (Sutent)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No