Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma (POWERRANGER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by CancerCare Manitoba
Sponsor:
Collaborators:
Nova Scotia Health Authority
CancerCare Manitoba
Information provided by (Responsible Party):
Dr. Gordon Buduhan, CancerCare Manitoba
ClinicalTrials.gov Identifier:
NCT01404156
First received: July 26, 2011
Last updated: October 22, 2015
Last verified: October 2015
  Purpose

The best treatment for resectable esophageal cancer or cancer between esophagus and stomach (GE junction) 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 / GE junction 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 / GE junction cancer (adenocarcinoma) 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
Adenocarcinoma, Gastroesophageal Junction
Drug: Epirubicin cisplatin 5-Fluorouracil
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: PreOperative Treatment With chEmotheRapy or chemoRAdiatioN in esophaGeal or gastroEsophageal adenocaRcinoma

Resource links provided by NLM:


Further study details as provided by CancerCare Manitoba:

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: 60
Study Start Date: September 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neoadjuvant Chemotherapy

Three 21-day cycles ECF preoperatively:

Epirubicin (50 mg per square meter of body-surface area) by intravenous bolus on day 1 Cisplatin: 60 mg per square meter intravenously with hydration on day 1 5-Fluorouracil: 200 mg per square meter daily for 21 days by continuous intravenous infusion

Drug: Epirubicin cisplatin 5-Fluorouracil

Three 21-day cycles ECF preoperatively:

Epirubicin (50 mg per square meter of body-surface area) by intravenous bolus on day 1 Cisplatin: 60 mg per square meter intravenously with hydration on day 1 5-Fluorouracil: 200 mg per square meter daily for 21 days by continuous intravenous infusion

Other Name: ECF
Experimental: Neoadjuvant Chemoradiation

1) -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 Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.

    1. Dose specifications:

      1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy.
      2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment.
Other: Carboplatin paclitaxel plus concurrent radiotherapy

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

  • 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 Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.

    1. Dose specifications:

      1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints.
      2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment .

  Eligibility

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

Inclusion Criteria:

  • adenocarcinoma esophagus / gastroesophageal junction
  • 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
  • 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 T2-4Nx; M
  • 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; diameter < 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 ClinicalTrials.gov identifier: NCT01404156

Contacts
Contact: Gordon Buduhan, MD MSc FRCSC 204-787-3109 gbuduhan@exchange.hsc.mb.ca
Contact: Kathi Klapp 204-787-2159 kathi.klapp@cancercare.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre / CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
Dr. Gordon Buduhan
Nova Scotia Health Authority
CancerCare Manitoba
  More Information

No publications provided

Responsible Party: Dr. Gordon Buduhan, MD MSc FRCSC Assistant Professor of Surgery Section of Thoracic Surgery,, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT01404156     History of Changes
Other Study ID Numbers: CDHA 174431-7 
Study First Received: July 26, 2011
Last Updated: October 22, 2015
Health Authority: Canada: Health Canada

Keywords provided by CancerCare Manitoba:
Esophageal cancer
Neoadjuvant
Chemotherapy
Chemoradiation
Surgery
Esophagectomy
Adenocarcinoma
Gastroesophageal

Additional relevant MeSH terms:
Esophageal Diseases
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Carboplatin
Cisplatin
Epirubicin
Fluorouracil
Paclitaxel
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2016