Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Squamous Cell
Adenocarcinoma of the Esophagus and Gastric Cardia
Interventions Drug: Chemotherapy
Radiation: Radiochemotherapy
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiochemotherapy Chemotherapy
Hide Arm/Group Description

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

Period Title: Overall Study
Started 90 91
Completed 90 91
Not Completed 0 0
Arm/Group Title Radiochemotherapy Chemotherapy Total
Hide Arm/Group Description

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 90 91 181
Hide Baseline Analysis Population Description
see Klevebro et al Annals of Oncology, primary outcome
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 91 participants 181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
  57.8%
55
  60.4%
107
  59.1%
>=65 years
38
  42.2%
36
  39.6%
74
  40.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 91 participants 181 participants
Female
18
  20.0%
14
  15.4%
32
  17.7%
Male
72
  80.0%
77
  84.6%
149
  82.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 90 participants 91 participants 181 participants
90 91 181
1.Primary Outcome
Title Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
Hide Description Chireac tumour regression grade
Time Frame Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiochemotherapy Chemotherapy
Hide Arm/Group Description:

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

Overall Number of Participants Analyzed 78 78
Measure Type: Count of Participants
Unit of Measure: Participants
22
  28.2%
7
   9.0%
2.Secondary Outcome
Title Safety of Respective Neoadjuvant Therapies.
Hide Description Safety profile of carrying out radical surgery after respective neoadjuvant therapy.
Time Frame Five years follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiochemotherapy Chemotherapy
Hide Arm/Group Description:

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

Overall Number of Participants Analyzed 90 91
Measure Type: Count of Participants
Unit of Measure: Participants
79
  87.8%
81
  89.0%
3.Secondary Outcome
Title HRQOL and Swallowing Function
Hide Description 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.
Time Frame Entry study up to Five years follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who responded to quality of Life instruments the EORTC QLQ-C30 and the oesophageal specific instrument
Arm/Group Title Radiochemotherapy Chemotherapy
Hide Arm/Group Description:

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

Overall Number of Participants Analyzed 80 74
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Mean global QoL
67
(62 to 72)
69
(63 to 74)
Dysphagia score all
27
(20 to 34)
31
(24 to 39)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiochemotherapy Chemotherapy
Hide Arm/Group Description

Radiochemotherapy + Surgery

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.

Chemotherapy + surgery

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.

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.

All-Cause Mortality
Radiochemotherapy Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Radiochemotherapy Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/90 (63.33%)      41/91 (45.05%)    
Blood and lymphatic system disorders     
Neutropenia/thrombocytopenia   5/90 (5.56%)  5 2/91 (2.20%)  2
Cardiac disorders     
Cardiovascular events   14/90 (15.56%)  14 7/91 (7.69%)  7
Death   2/90 (2.22%)  2 1/91 (1.10%)  1
Gastrointestinal disorders     
Nausea and vomiting   6/90 (6.67%)  6 2/91 (2.20%)  2
Gastrointestinal symptoms   5/90 (5.56%)  5 1/91 (1.10%)  1
General disorders     
Other   3/90 (3.33%)  3 3/91 (3.30%)  3
Infections and infestations     
Infection   5/90 (5.56%)  5 5/91 (5.49%)  5
Investigations     
SAE   57/90 (63.33%)  57 41/91 (45.05%)  41
Metabolism and nutrition disorders     
Nutritional deficiency   13/90 (14.44%)  13 13/91 (14.29%)  13
Renal and urinary disorders     
Renal failure   4/90 (4.44%)  4 7/91 (7.69%)  7
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiochemotherapy Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/90 (0.00%)      0/91 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fredrik Klevebro
Organization: Karolinska Institutet
Phone: +46858580000 ext 11111
EMail: fredrik.klevebro@ki.se
Publications of Results:
Layout table for additonal information
Responsible Party: Magnus Nilsson, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01362127    
Other Study ID Numbers: EU-nr 2006-001785-16
2006-001785-16 ( EudraCT Number )
First Submitted: May 26, 2011
First Posted: May 27, 2011
Results First Submitted: April 16, 2019
Results First Posted: February 26, 2020
Last Update Posted: February 26, 2020