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Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers (GABLE)

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: NCT03515941
Recruitment Status : Terminated (The PI has decided to close the study due to the outdated study design.)
First Posted : May 4, 2018
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Tannaz Armaghany, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Cancer
Interventions Drug: Oxaliplatin
Drug: Capecitabine
Drug: Leucovorin
Drug: 5-fluorouracil
Radiation: radiation
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Hide Arm/Group Description

Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle

Oxaliplatin: 130 mg/m2 by IV (Arm 1)

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

radiation: 45 Gy in 1.8 Gy/fraction

Period Title: Overall Study
Started 4 2
Completed 3 2
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation Total
Hide Arm/Group Description

Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle

Oxaliplatin: 130 mg/m2 by IV (Arm 1)

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

radiation: 45 Gy in 1.8 Gy/fraction

Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 2 participants 6 participants
57.9  (12.6) 38.5  (6.2) 51.4  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
2
  50.0%
2
 100.0%
4
  66.7%
Male
2
  50.0%
0
   0.0%
2
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Hispanic or Latino
3
  75.0%
2
 100.0%
5
  83.3%
Not Hispanic or Latino
1
  25.0%
0
   0.0%
1
  16.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
American Indian or Alaska Native
1
  25.0%
0
   0.0%
1
  16.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  75.0%
2
 100.0%
5
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
ECOG performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
ECOG score 0
3
  75.0%
2
 100.0%
5
  83.3%
ECOG score 1
1
  25.0%
0
   0.0%
1
  16.7%
[1]
Measure Description:

The Eastern Cooperative Oncology Group (ECOG) performance score is a scale to assess how the disease affects the daily living abilities of the patient. ECOG score ranges from 0 to 5, with 0 denoting perfect health and 5 death. Less ECOG score is considered better living ability.

ECOG 0:Fully active, able to carry on all pre-disease performance without restriction ECOG 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

1.Primary Outcome
Title Number of Participants Who Complete the Recommended Therapy From Each Arm
Hide Description The number of patients who complete the recommended therapy will be counted for each arm.
Time Frame From date of assigned therapy up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Hide Arm/Group Description:

Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle

Oxaliplatin: 130 mg/m2 by IV (Arm 1)

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

radiation: 45 Gy in 1.8 Gy/fraction

Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
 100.0%
2.Secondary Outcome
Title Median Time to Recurrence
Hide Description Disease recurrence will be defined as radiographic tumor evidence detected by surveillance imaging. Confirmation of recurrence by biopsy will be at the discretion of the treating physician. This study closed early on June 18, 2020. It was earlier than one planned because of the lack of accrual.
Time Frame From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who are enrolled on the study and begin any of their intended post-operative adjuvant therapy will be counted as evaluable for the study. This inclusion will be regardless of how much of the postoperative treatment they ultimately receive.
Arm/Group Title Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Hide Arm/Group Description:

Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle

Oxaliplatin: 130 mg/m2 by IV (Arm 1)

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

radiation: 45 Gy in 1.8 Gy/fraction

Overall Number of Participants Analyzed 4 2
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(5.96 to NA)
NA [2] 
(NA to NA)
[1]
The median recurrence time was NA therefore the upper 95% confidence interval is NA.
[2]
There was no recurrence occurred during the time period we observed. Therefore, the recurrence has not been reached to the median.
Time Frame From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Hide Arm/Group Description

Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle

Oxaliplatin: 130 mg/m2 by IV (Arm 1)

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.

Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)

5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

radiation: 45 Gy in 1.8 Gy/fraction

All-Cause Mortality
Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/2 (50.00%)    
Gastrointestinal disorders     
Gastrointestinal pain  1  0/4 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Adjuvant Chemotherapy Arm 2: Adjuvant Chemoradiation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Gastrointestinal disorders     
Constipation  1  0/4 (0.00%)  0 2/2 (100.00%)  2
Diarrhea  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Nausea  1  1/4 (25.00%)  1 2/2 (100.00%)  2
Vomiting  1  2/4 (50.00%)  2 2/2 (100.00%)  2
Gastroesophageal reflux disease  1  1/4 (25.00%)  1 0/2 (0.00%)  0
General disorders     
Fatigue  1  2/4 (50.00%)  2 2/2 (100.00%)  2
General disorders and administration site conditions - Other, specify  1 [1]  0/4 (0.00%)  0 1/2 (50.00%)  1
Pain  1  0/4 (0.00%)  0 2/2 (100.00%)  2
Infections and infestations     
Upper respiratory infection  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Injury, poisoning and procedural complications     
Bruising  1  1/4 (25.00%)  1 0/2 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/4 (25.00%)  1 0/2 (0.00%)  0
Alkaline phosphatase increased  1  1/4 (25.00%)  1 2/2 (100.00%)  2
Aspartate aminotransferase increased  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Lymphocyte count decreased  1  1/4 (25.00%)  1 2/2 (100.00%)  2
Neutrophil count decreased  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Platelet count decreased  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Weight loss  1  1/4 (25.00%)  1 0/2 (0.00%)  0
White blood cell decreased  1  0/4 (0.00%)  0 2/2 (100.00%)  2
Metabolism and nutrition disorders     
Anorexia  1  0/4 (0.00%)  0 2/2 (100.00%)  2
Hyperglycemia  1  1/4 (25.00%)  1 2/2 (100.00%)  2
Hypernatremia  1  1/4 (25.00%)  1 0/2 (0.00%)  0
Hypocalcemia  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Hypoglycemia  1  1/4 (25.00%)  1 1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders     
Neck pain  1  1/4 (25.00%)  1 0/2 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Headache  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Peripheral motor neuropathy  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Psychiatric disorders     
Anxiety  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Insomnia  1  0/4 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders     
Skin hyperpigmentation  1  0/4 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
This adverse event was monitored/assessed without regard to the specific Adverse Event Term.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eunji Jo
Organization: Baylor College of Medicine
Phone: 713-798-4923
EMail: ejo@bcm.edu
Publications:
Layout table for additonal information
Responsible Party: Tannaz Armaghany, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03515941    
Other Study ID Numbers: H-40682
First Submitted: April 24, 2018
First Posted: May 4, 2018
Results First Submitted: August 13, 2020
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020