Trial Outcomes & Findings for Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia (NCT NCT01362127)
NCT ID: NCT01362127
Last Updated: 2020-02-26
Results Overview
Chireac tumour regression grade
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
Radiochemotherapy
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
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 Study
STARTED
|
90
|
91
|
|
Overall Study
COMPLETED
|
90
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Baseline characteristics by cohort
| Measure |
Radiochemotherapy
n=90 Participants
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
n=91 Participants
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
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
181 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Radiochemotherapy
n=78 Participants
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
n=78 Participants
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.
|
|---|---|---|
|
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
|
22 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Five years follow upSafety profile of carrying out radical surgery after respective neoadjuvant therapy.
Outcome measures
| Measure |
Radiochemotherapy
n=90 Participants
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
n=91 Participants
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.
|
|---|---|---|
|
Safety of Respective Neoadjuvant Therapies.
|
79 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Entry study up to Five years follow upPopulation: Number of patients who responded to quality of Life instruments the EORTC QLQ-C30 and the oesophageal specific instrument
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.
Outcome measures
| Measure |
Radiochemotherapy
n=80 Participants
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
n=74 Participants
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.
|
|---|---|---|
|
HRQOL and Swallowing Function
Mean global QoL
|
67 units on a scale
Interval 62.0 to 72.0
|
69 units on a scale
Interval 63.0 to 74.0
|
|
HRQOL and Swallowing Function
Dysphagia score all
|
27 units on a scale
Interval 20.0 to 34.0
|
31 units on a scale
Interval 24.0 to 39.0
|
Adverse Events
Radiochemotherapy
Serious events: 57 serious events
Other events: 0 other events
Deaths: 0 deaths
Chemotherapy
Serious events: 41 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiochemotherapy
n=90 participants at risk
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
n=91 participants at risk
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.
|
|---|---|---|
|
Investigations
SAE
|
63.3%
57/90 • Number of events 57
|
45.1%
41/91 • Number of events 41
|
|
Infections and infestations
Infection
|
5.6%
5/90 • Number of events 5
|
5.5%
5/91 • Number of events 5
|
|
Gastrointestinal disorders
Nausea and vomiting
|
6.7%
6/90 • Number of events 6
|
2.2%
2/91 • Number of events 2
|
|
Metabolism and nutrition disorders
Nutritional deficiency
|
14.4%
13/90 • Number of events 13
|
14.3%
13/91 • Number of events 13
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
5.6%
5/90 • Number of events 5
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
Cardiovascular events
|
15.6%
14/90 • Number of events 14
|
7.7%
7/91 • Number of events 7
|
|
Renal and urinary disorders
Renal failure
|
4.4%
4/90 • Number of events 4
|
7.7%
7/91 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia/thrombocytopenia
|
5.6%
5/90 • Number of events 5
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Other
|
3.3%
3/90 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Cardiac disorders
Death
|
2.2%
2/90 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place