Trial Outcomes & Findings for S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery (NCT NCT00335959)

Last Updated: 2012-08-17

Results Overview

Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

17-19 weeks

Results posted on

2012-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy, Chemoradiation, Surgery Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Overall Study STARTED	7
Overall Study Eligible	6
Overall Study Eligible and Began Protocol Therapy	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy, Chemoradiation, Surgery Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Overall Study Adverse Event	2
Overall Study Ineligible	1

Baseline Characteristics

S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy, Chemoradiation, Surgery n=6 Participants Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Age Continuous	72 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 17-19 weeks

Population: Eligible patients who completed pre-operative therapy were assessed for response.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation and Surgery n=5 Participants Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Pathologic Complete Response Unconfirmed Complete Response	1 participants
Pathologic Complete Response Unconfirmed Partial Response	2 participants
Pathologic Complete Response Stable/No Response	2 participants
Pathologic Complete Response Increasing Disease	1 participants
Pathologic Complete Response Assessment Inadequate	1 participants

SECONDARY outcome

Timeframe: Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.

Population: Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation and Surgery n=6 Participants Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anorexia	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dehydration	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Gastrointestinal-Other (Specify)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemoglobin	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Leukocytes (total WBC)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lymphopenia	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Necrosis, GI - Small bowel NOS	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Phosphate, serum-low (hypophosphatemia)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Platelets	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Potassium, serum-low (hypokalemia)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sodium, serum-low (hyponatremia)	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	1 Participants with a given type of AE

Adverse Events

Chemotherapy, Chemoradiation and Surgery

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy, Chemoradiation and Surgery n=6 participants at risk Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Gastrointestinal disorders Gastrointestinal-Other (Specify)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.

Other adverse events

Other adverse events
Measure	Chemotherapy, Chemoradiation and Surgery n=6 participants at risk Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Blood and lymphatic system disorders Hemoglobin	66.7% 4/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Cardiac disorders Ventricular arrhythmia - PVCs	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Constipation	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Diarrhea	50.0% 3/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Heartburn/dyspepsia	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Nausea	100.0% 6/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Necrosis, GI - Small bowel NOS	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Pain - Abdomen NOS	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Pain - Esophagus	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Pain - Intestine	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Pain - Stomach	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Gastrointestinal disorders Vomiting	50.0% 3/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 6/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary tract	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Alkaline phosphatase	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Creatinine	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Leukocytes (total WBC)	66.7% 4/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Lymphopenia	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Neutrophils/granulocytes (ANC/AGC)	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Platelets	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Investigations Weight loss	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Dehydration	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	33.3% 2/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	50.0% 3/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Musculoskeletal and connective tissue disorders Pain - Joint	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Nervous system disorders Neuropathy: sensory	66.7% 4/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Psychiatric disorders Mood alteration - anxiety	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Skin and subcutaneous tissue disorders Photosensitivity	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Vascular disorders Hypotension	16.7% 1/6 • Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place