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Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia (NeoRes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362127
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
University Hospital, Umeå
Region Örebro County
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Information provided by (Responsible Party):
Magnus Nilsson, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE May 27, 2011
Results First Submitted Date  ICMJE April 16, 2019
Results First Posted Date  ICMJE February 26, 2020
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. [ Time Frame: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy. ]
Chireac tumour regression grade
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
To evaluate whether radiochemotherapy gives higher complete histological response (pCR) after resection than chemotherapy alone in patients with resectable carcinoma of the esophagus and cardia. [ Time Frame: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • Safety of Respective Neoadjuvant Therapies. [ Time Frame: Five years follow up ]
    Safety profile of carrying out radical surgery after respective neoadjuvant therapy.
  • HRQOL and Swallowing Function [ Time Frame: Entry study up to Five years follow up ]
    The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
To evaluate the safety of respective neoadjuvant therapies. [ Time Frame: Three years follow up ]
To assess the safety profile of carrying out radical surgery after respective neoadjuvant therapy. To study the overall and disease free survival in respective groups. To evaluate if pretreatment tumor characteristics predict the pCR and oncomplete pCR rates.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Official Title  ICMJE Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy
Brief Summary The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Squamous Cell
  • Adenocarcinoma of the Esophagus and Gastric Cardia
Intervention  ICMJE
  • Drug: Chemotherapy
    Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
    Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
  • Radiation: Radiochemotherapy
    Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
    Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Study Arms  ICMJE
  • Active Comparator: Radiochemotherapy
    Arm I: Radiochemotherapy + Surgery
    Interventions:
    • Drug: Chemotherapy
    • Radiation: Radiochemotherapy
  • Active Comparator: Chemotherapy
    Arm II: Chemotherapy + surgery
    Intervention: Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2020)
181
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
180
Actual Study Completion Date  ICMJE June 25, 2018
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
  • Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
  • Adequate haemotological function, defined as having WBC > 3 x 10(9)/litre and platelets > 100 x 10 (9)/litre.
  • Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate > 60 ml/min.
  • Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a

Exclusion Criteria:

  • Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
  • Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
  • Concomitant malignancy (< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
  • Patients being unable tom comply with the protocol
  • Tumor stage T1 N0, T4 NX or TXNXM1b
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362127
Other Study ID Numbers  ICMJE EU-nr 2006-001785-16
2006-001785-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Magnus Nilsson, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE
  • University Hospital, Umeå
  • Region Örebro County
  • Sahlgrenska University Hospital, Sweden
  • Ullevaal University Hospital
  • Haukeland University Hospital
  • Oslo University Hospital
  • St. Olavs Hospital
  • Malarhospital Eskilstuna
Investigators  ICMJE
Principal Investigator: Magnus Nilsson, Professor Karolinska University Hospital, Gastrocentrum
Study Chair: Lars Lundell, Professor Karolinska University Hospital, Gastrocentrum
PRS Account Karolinska University Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP