Trial Outcomes & Findings for Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (NCT NCT00478699)
NCT ID: NCT00478699
Last Updated: 2024-12-12
Results Overview
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
5 years
Results posted on
2024-12-12
Participant Flow
The recruitment was 500 patients (intention to treat patient) in 47 centers between June 2007 and May 2013.
Screening details: Experimental arm: according to the BRAC1 levels of the tumor tissue, receive different combination of treatment.
Participant milestones
| Measure |
Control Arm
Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4.
|
Experimental Arm
Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
* Low expression of BRCA1 gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
392
|
|
Overall Study
COMPLETED
|
101
|
355
|
|
Overall Study
NOT COMPLETED
|
7
|
37
|
Reasons for withdrawal
| Measure |
Control Arm
Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4.
|
Experimental Arm
Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
* Low expression of BRCA1 gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Overall Study
Inclusion Error
|
1
|
7
|
|
Overall Study
Not receive study treatment
|
6
|
30
|
Baseline Characteristics
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
Baseline characteristics by cohort
| Measure |
Control Arm
n=101 Participants
Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4.
|
Experimental Arm
n=355 Participants
Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
* Low expression of BRCA1 gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
61 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
101 participants
n=5 Participants
|
355 participants
n=7 Participants
|
456 participants
n=5 Participants
|
|
Smoking habit
Former smoker
|
62 participants
n=5 Participants
|
221 participants
n=7 Participants
|
283 participants
n=5 Participants
|
|
Smoking habit
Smoker
|
28 participants
n=5 Participants
|
102 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Smoking habit
Never smoker
|
11 participants
n=5 Participants
|
32 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Histology
Adenocarcinomas
|
47 participants
n=5 Participants
|
175 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Histology
Squamous
|
46 participants
n=5 Participants
|
155 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Histology
Other
|
8 participants
n=5 Participants
|
25 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Staging T
T1
|
22 participants
n=5 Participants
|
68 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Staging T
T2
|
64 participants
n=5 Participants
|
230 participants
n=7 Participants
|
294 participants
n=5 Participants
|
|
Staging T
T3
|
15 participants
n=5 Participants
|
57 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Staging N
N1
|
62 participants
n=5 Participants
|
215 participants
n=7 Participants
|
277 participants
n=5 Participants
|
|
Staging N
N2
|
39 participants
n=5 Participants
|
140 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Stage
IIA
|
14 participants
n=5 Participants
|
38 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Stage
IIB
|
37 participants
n=5 Participants
|
142 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Stage
IIIA
|
50 participants
n=5 Participants
|
175 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Treatment according to BRCA1 level
Control: Docetaxel and Cisplatin
|
101 participants
n=5 Participants
|
0 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Treatment according to BRCA1 level
Experimental: BRCA1 Low: Gemcitabine / Cisplatin
|
0 participants
n=5 Participants
|
155 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Treatment according to BRCA1 level
Experimental BRCA1 medium: Docetaxel / Cisplatin
|
0 participants
n=5 Participants
|
99 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Treatment according to BRCA1 level
Experimental BRCA1 High: Docetaxel
|
0 participants
n=5 Participants
|
101 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Treatment compliance
Completed
|
84 participants
n=5 Participants
|
307 participants
n=7 Participants
|
391 participants
n=5 Participants
|
|
Treatment compliance
Not completed
|
17 participants
n=5 Participants
|
48 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Only those patients validated by protocol. Patients not valid by protocol will be all those who, having given their informed consent do not receive the study treatment because of any reason and/or those patients who after treatment with chemotherapy do not have a minimum of six months of follow-up.
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.
Outcome measures
| Measure |
Control Arm
n=101 Participants
Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4.
|
Experimental Arm
n=355 Participants
Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
* Low expression of BRCA1 gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Estimated Overall Survival
Control arm vs Experimental arm
|
0.54 proportion of participants
Interval 0.44 to 0.64
|
0.56 proportion of participants
Interval 0.51 to 0.61
|
|
Estimated Overall Survival
Control arm vs Gemcitabine /Cisplatin Experimental arm
|
0.54 proportion of participants
Interval 0.44 to 0.64
|
0.56 proportion of participants
Interval 0.47 to 0.64
|
|
Estimated Overall Survival
Control arm vs Docetaxel /Cisplatin Experimental arm
|
0.54 proportion of participants
Interval 0.44 to 0.64
|
0.53 proportion of participants
Interval 0.42 to 0.62
|
|
Estimated Overall Survival
Control arm vs Docetaxel Experimental Arm
|
0.54 proportion of participants
Interval 0.44 to 0.64
|
0.60 proportion of participants
Interval 0.49 to 0.69
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants are analyzed by protocol.
To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.
Outcome measures
| Measure |
Control Arm
n=101 Participants
Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4.
|
Experimental Arm
n=355 Participants
Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
* Low expression of BRCA1 gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Disease Free Survival
|
38.7 Month
Interval 18.6 to 58.8
|
32.7 Month
Interval 24.1 to 41.2
|
Adverse Events
Control Group
Serious events: 36 serious events
Other events: 105 other events
Deaths: 3 deaths
Experimental Group:All Reported Adverse Events Related to Study Medication
Serious events: 66 serious events
Other events: 384 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Control Group
n=108 participants at risk
Control group
\- Docetaxel 75 mg/m2, y cisplatin 75 mg/m2, both day 1 every 21 days. Total cycles: 4.
|
Experimental Group:All Reported Adverse Events Related to Study Medication
n=392 participants at risk
Include participants in experimental arm
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
* Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Vascular disorders
Pulmonary thromboembolism
|
1.9%
2/108 • Number of events 2 • 70 month
|
1.5%
6/392 • Number of events 6 • 70 month
|
|
Vascular disorders
Thrombolysis
|
1.9%
2/108 • Number of events 2 • 70 month
|
0.51%
2/392 • Number of events 2 • 70 month
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/108 • 70 month
|
0.26%
1/392 • Number of events 1 • 70 month
|
|
Cardiac disorders
Acute myocardial infarction
|
0.93%
1/108 • Number of events 1 • 70 month
|
0.00%
0/392 • 70 month
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.4%
22/108 • Number of events 22 • 70 month
|
7.4%
29/392 • Number of events 29 • 70 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
1.9%
2/108 • Number of events 2 • 70 month
|
3.6%
14/392 • Number of events 14 • 70 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/108 • 70 month
|
0.26%
1/392 • Number of events 1 • 70 month
|
|
General disorders
Anorexy
|
0.93%
1/108 • Number of events 1 • 70 month
|
0.00%
0/392 • 70 month
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
2/108 • Number of events 2 • 70 month
|
2.0%
8/392 • Number of events 8 • 70 month
|
|
Gastrointestinal disorders
Vomits
|
0.00%
0/108 • 70 month
|
0.77%
3/392 • Number of events 3 • 70 month
|
|
Renal and urinary disorders
Acute kidney failure
|
0.93%
1/108 • Number of events 1 • 70 month
|
0.00%
0/392 • 70 month
|
|
Skin and subcutaneous tissue disorders
Palmoplantar disease
|
0.00%
0/108 • 70 month
|
0.26%
1/392 • Number of events 1 • 70 month
|
|
Renal and urinary disorders
Urinary tract infection
|
0.93%
1/108 • Number of events 1 • 70 month
|
0.77%
3/392 • Number of events 3 • 70 month
|
|
Musculoskeletal and connective tissue disorders
Broken arm
|
0.93%
1/108 • Number of events 1 • 70 month
|
0.00%
0/392 • 70 month
|
|
Vascular disorders
Hypotension
|
1.9%
2/108 • Number of events 2 • 70 month
|
0.00%
0/392 • 70 month
|
Other adverse events
| Measure |
Control Group
n=108 participants at risk
Control group
\- Docetaxel 75 mg/m2, y cisplatin 75 mg/m2, both day 1 every 21 days. Total cycles: 4.
|
Experimental Group:All Reported Adverse Events Related to Study Medication
n=392 participants at risk
Include participants in experimental arm
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
* Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
|
|---|---|---|
|
Vascular disorders
Phlebitis
|
1.9%
2/108 • Number of events 2 • 70 month
|
2.3%
9/392 • Number of events 9 • 70 month
|
|
Immune system disorders
Allergic reaction
|
0.93%
1/108 • Number of events 1 • 70 month
|
3.8%
15/392 • Number of events 15 • 70 month
|
|
General disorders
Asthenia
|
29.6%
32/108 • Number of events 32 • 70 month
|
67.9%
266/392 • Number of events 266 • 70 month
|
|
General disorders
Fever
|
18.5%
20/108 • Number of events 20 • 70 month
|
5.1%
20/392 • Number of events 20 • 70 month
|
|
General disorders
Abdominal pain
|
5.6%
6/108 • Number of events 6 • 70 month
|
2.8%
11/392 • Number of events 11 • 70 month
|
|
Cardiac disorders
Cardiac disorders
|
1.9%
2/108 • Number of events 2 • 70 month
|
0.51%
2/392 • Number of events 2 • 70 month
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.0%
81/108 • Number of events 81 • 70 month
|
56.1%
220/392 • Number of events 220 • 70 month
|
|
Blood and lymphatic system disorders
Leukocites
|
7.4%
8/108 • Number of events 8 • 70 month
|
20.4%
80/392 • Number of events 80 • 70 month
|
|
Blood and lymphatic system disorders
Neutrophils
|
4.6%
5/108 • Number of events 5 • 70 month
|
35.2%
138/392 • Number of events 138 • 70 month
|
|
Blood and lymphatic system disorders
Platelets
|
4.6%
5/108 • Number of events 5 • 70 month
|
12.8%
50/392 • Number of events 50 • 70 month
|
|
Blood and lymphatic system disorders
Epistaxis
|
3.7%
4/108 • Number of events 4 • 70 month
|
1.3%
5/392 • Number of events 5 • 70 month
|
|
General disorders
Edema
|
1.9%
2/108 • Number of events 2 • 70 month
|
3.1%
12/392 • Number of events 12 • 70 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
75.9%
82/108 • Number of events 82 • 70 month
|
6.4%
25/392 • Number of events 25 • 70 month
|
|
Nervous system disorders
Sensitivity in sensory processing
|
3.7%
4/108 • Number of events 4 • 70 month
|
12.0%
47/392 • Number of events 47 • 70 month
|
|
Eye disorders
Conjunctivitis
|
1.9%
2/108 • Number of events 2 • 70 month
|
0.77%
3/392 • Number of events 3 • 70 month
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
4/108 • Number of events 4 • 70 month
|
1.0%
4/392 • Number of events 4 • 70 month
|
|
Gastrointestinal disorders
Anorexy
|
10.2%
11/108 • Number of events 11 • 70 month
|
16.1%
63/392 • Number of events 63 • 70 month
|
|
Gastrointestinal disorders
Constipation
|
9.3%
10/108 • Number of events 10 • 70 month
|
14.5%
57/392 • Number of events 57 • 70 month
|
|
Gastrointestinal disorders
Diarrhea
|
18.5%
20/108 • Number of events 20 • 70 month
|
28.1%
110/392 • Number of events 110 • 70 month
|
|
Gastrointestinal disorders
Mucositis
|
4.6%
5/108 • Number of events 5 • 70 month
|
23.7%
93/392 • Number of events 93 • 70 month
|
|
Gastrointestinal disorders
Nausea
|
18.5%
20/108 • Number of events 20 • 70 month
|
45.9%
180/392 • Number of events 180 • 70 month
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
5/108 • Number of events 5 • 70 month
|
32.1%
126/392 • Number of events 126 • 70 month
|
|
Gastrointestinal disorders
Epigastralgia
|
8.3%
9/108 • Number of events 9 • 70 month
|
3.3%
13/392 • Number of events 13 • 70 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
2/108 • Number of events 2 • 70 month
|
36.2%
142/392 • Number of events 142 • 70 month
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/108 • Number of events 2 • 70 month
|
6.4%
25/392 • Number of events 25 • 70 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
2/108 • Number of events 2 • 70 month
|
3.8%
15/392 • Number of events 15 • 70 month
|
|
Metabolism and nutrition disorders
GGT alteration
|
83.3%
90/108 • Number of events 90 • 70 month
|
10.7%
42/392 • Number of events 42 • 70 month
|
|
Metabolism and nutrition disorders
Creatinine alteration
|
9.3%
10/108 • Number of events 10 • 70 month
|
8.4%
33/392 • Number of events 33 • 70 month
|
|
Metabolism and nutrition disorders
GPT/ GOT alterations
|
28.7%
31/108 • Number of events 31 • 70 month
|
9.4%
37/392 • Number of events 37 • 70 month
|
|
Metabolism and nutrition disorders
LDH alteration
|
26.9%
29/108 • Number of events 29 • 70 month
|
7.4%
29/392 • Number of events 29 • 70 month
|
|
Infections and infestations
Infection
|
32.4%
35/108 • Number of events 35 • 70 month
|
13.0%
51/392 • Number of events 51 • 70 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place