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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

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Adenocarcinoma of the Esophagus and Gastric Cardia Drug: Chemotherapy Radiation: Radiochemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy
Actual Study Start Date : October 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Radiochemotherapy
Arm I: Radiochemotherapy + Surgery
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.

Active Comparator: Chemotherapy
Arm II: Chemotherapy + surgery
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety of Respective Neoadjuvant Therapies. [ Time Frame: Five years follow up ]
    Safety profile of carrying out radical surgery after respective neoadjuvant therapy.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362127


Locations
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Sweden
Upper Digestive Diseases. Department of surgery, Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
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
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Principal Investigator: Magnus Nilsson, Professor Karolinska University Hospital, Gastrocentrum
Study Chair: Lars Lundell, Professor Karolinska University Hospital, Gastrocentrum
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magnus Nilsson, Ass Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01362127    
Other Study ID Numbers: EU-nr 2006-001785-16
2006-001785-16 ( EudraCT Number )
First Posted: May 27, 2011    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Magnus Nilsson, Karolinska University Hospital:
Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell
Cisplatin
Carboplatin
Oxaliplatin
Antineoplastic Agents