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

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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Recruitment Status : Terminated (The PI has decided to close the study due to the outdated study design.)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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm 1: Adjuvant Chemotherapy	Arm 2: Adjuvant Chemoradiation
Arm/Group Description	Three cycles of chemo with CAPEOX (...	Three cycles of chemo with Capecita...
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

Baseline Characteristics

Arm/Group Title		Arm 1: Adjuvant Chemotherapy	Arm 2: Adjuvant Chemoradiation	Total
Arm/Group Description		Three cycles of chemo with CAPEOX (...	Three cycles of chemo with Capecita...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Number of Participants Who Complete the Recommended Therapy From Each Arm
Description	The number of patients who complete the recommended therapy will be co...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm 1: Adjuvant Chemotherapy	Arm 2: Adjuvant Chemoradiation
Arm/Group Description:	Three cycles of chemo with CAPEOX (...	Three cycles of chemo with Capecita...
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
Description	Disease recurrence will be defined as radiographic tumor evidence dete...
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

Outcome Measure Data

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
Arm/Group Description:	Three cycles of chemo with CAPEOX (...	Three cycles of chemo with Capecita...
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.

Adverse Events

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
Arm/Group Description	Three cycles of chemo with CAPEOX (...		Three cycles of chemo with Capecita...
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%)
Serious Adverse Events 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
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.

Limitations and Caveats

[Not Specified]

More Information

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:

Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20.

Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30.

Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

Ychou M, Boige V, Pignon JP, Conroy T, Bouché O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Genève J, Lasser P, Rougier P. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011 May 1;29(13):1715-21. doi: 10.1200/JCO.2010.33.0597. Epub 2011 Mar 28.

Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB 3rd, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. J Clin Oncol. 2016 Aug 10;34(23):2736-42. doi: 10.1200/JCO.2015.65.5092. Epub 2016 Jul 5.

Dikken JL, van Sandick JW, Maurits Swellengrebel HA, Lind PA, Putter H, Jansen EP, Boot H, van Grieken NC, van de Velde CJ, Verheij M, Cats A. Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS). BMC Cancer. 2011 Aug 2;11:329. doi: 10.1186/1471-2407-11-329.

Smyth EC, Fassan M, Cunningham D, Allum WH, Okines AF, Lampis A, Hahne JC, Rugge M, Peckitt C, Nankivell M, Langley R, Ghidini M, Braconi C, Wotherspoon A, Grabsch HI, Valeri N. Effect of Pathologic Tumor Response and Nodal Status on Survival in the Medical Research Council Adjuvant Gastric Infusional Chemotherapy Trial. J Clin Oncol. 2016 Aug 10;34(23):2721-7. doi: 10.1200/JCO.2015.65.7692. Epub 2016 Jun 13.

Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, Lim HY, Choi MG, Sohn TS, Noh JH, Bae JM, Ahn YC, Sohn I, Jung SH, Park CK, Kim KM, Kang WK. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012 Jan 20;30(3):268-73. doi: 10.1200/JCO.2011.39.1953. Epub 2011 Dec 19.

Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.

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

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