Neoadjuvant Chemotherapy vs. Chemoradiation for Resectable Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Nova Scotia Health Authority.
Recruitment status was  Recruiting
Capital Health, Canada
Information provided by (Responsible Party):
Gordon Buduhan, Capital District Health Authority, Canada Identifier:
First received: July 26, 2011
Last updated: January 5, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Esophageal Cancer
Adenocarcinoma, Esophageal
Squamous Cell Carcinoma, Esophageal
Carcinoma, Gastroesophageal Junction
Drug: carboplatin and paclitaxel
Other: Carboplatin paclitaxel plus concurrent radiotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiation in Patients With Surgically Resectable Esophageal Cancer: a Pilot Randomized Study

Resource links provided by NLM:

Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • compliance with assigned neoadjuvant treatment [ Time Frame: 5 weeks for chemoradiation arm, 6 weeks for chemotherapy arm ] [ Designated as safety issue: Yes ]
    - >50% patients allocated for randomization will start and complete treatment without major protocol violation

  • treatment response [ Time Frame: 5 weeks for chemoradiation arm, 6 weeks for chemotherapy arm ] [ Designated as safety issue: No ]
    >30% of patients in both treatment arms demonstrate partial or complete response as defined by RECIST guidelines on restaging CT PET, and / or Mandard TRG 1-3 on pathologic staging

Secondary Outcome Measures:
  • survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    3 year overall- and disease-free survival

  • quality of life [ Time Frame: baseline, 3, 6, 9, 12 months post treatment ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Version 3.0

Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neoadjuvant Chemotherapy Drug: carboplatin and paclitaxel

2 cycles carboplatin and paclitaxel days 1, 8, 15 given every 4 weeks:

  • paclitaxel: 75 mg / m2 IV in 250 ml normal saline (NS) over 1 hour
  • carboplatin: dosed to an area under the curve of 3, by Calvert formula, as a 1 hour IV infusion
Experimental: Neoadjuvant Chemoradiation Other: Carboplatin paclitaxel plus concurrent radiotherapy

5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29

  • paclitaxel: 50 mg / m2 IV over 1 hour
  • carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion, diluted in 500 ml Dextrose 5% Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.

    1. Dose specifications:

      1. Total radiation prescription dose 45- 50.4 Gy given in 25-28 fractions of 1.8 Gy per fractions, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01404156

Contact: Gordon Buduhan, MD MSc FRCSC 902-473-8337
Contact: Erin Little 902-473-3735

Canada, Nova Scotia
QEII Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Gordon Buduhan
Capital Health, Canada
  More Information

No publications provided

Responsible Party: Gordon Buduhan, MD MSc FRCSC Assistant Professor of Surgery Division of Thoracic Surgery,, Capital District Health Authority, Canada Identifier: NCT01404156     History of Changes
Other Study ID Numbers: CDHA 147937-7
Study First Received: July 26, 2011
Last Updated: January 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Nova Scotia Health Authority:
Esophageal cancer

Additional relevant MeSH terms:
Esophageal Diseases
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on August 26, 2015