Neoadjuvant Chemotherapy vs. Chemoradiation for Resectable Esophageal Cancer
Conditions
Esophageal Cancer - Adenocarcinoma, Esophageal - Squamous Cell Carcinoma, Esophageal - Carcinoma, Gastroesophageal Junction
Conditions: official terms
Adenocarcinoma - Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
Esophageal cancer, Neoadjuvant, Chemotherapy, Chemoradiation, Surgery, Esophagectomy
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: carboplatin and paclitaxel Type: Drug
Name: Carboplatin paclitaxel plus concurrent radiotherapy Type: Other
Overall Status
Recruiting
Summary
The best treatment for resectable esophageal cancer is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either chemotherapy or chemotherapy plus radiation (chemoradiation) is given before surgery (preoperative), compared to surgery alone. However it is unknown which of these treatments (preoperative chemotherapy or preoperative chemoradiation) is more effective in improving survival. A study where patients with resectable esophageal cancer are chosen at random to receive one of the two preoperative treatments would help determine if one form of treatment improves survival compared to the other.

Patients with localized esophageal cancer will be randomized to receive either preoperative chemotherapy or preoperative chemoradiation followed by surgery.

The main objective of this pilot trial is to determine the possibility of conducting a larger study with many centers participating. If this study proves to be feasible with enough patients enrolled and able to tolerate treatments without major side effects then we can hopefully proceed to perform a larger multi-center trial to look for survival outcome differences between patients who receive preoperative chemotherapy and those who receive preoperative chemoradiation. The results of this trial would ultimately help us choose the most effective treatment of resectable esophageal cancer and hopefully improve survival.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- age < 75 years

- absolute neutrophil count ≥ 1.5 x 109 / L

- platelet count > 100 x 109 / L

- creatinine clearance > 50 ml / min

- bilirubin < 1.5x upper limit normal

- FEV1 > 1.0 L

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- negative serum / urine pregnancy test for females of childbearing age

- no previous primary / recurrent malignancy in last 5 years

- no previous chemotherapy for esophageal cancer

- no previous radiation therapy that would overlap required radiation fields

- no major systemic illness(es) that would limit life expectancy <2 years

- no psychiatric / cognitive illness that would limit ability to give informed consent

- cT1N1 or T2-3Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification(36)

- proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia

- tumor length < 8cm; radial size < 5 cm
Location
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Status: Recruiting
Start Date
December 2011
Completion Date
February 2013
Sponsors
Gordon Buduhan
Source
Nova Scotia Health Authority
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page