Trial Outcomes & Findings for Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ) (NCT NCT00525785)
NCT ID: NCT00525785
Last Updated: 2020-02-10
Results Overview
The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment
Results posted on
2020-02-10
Participant Flow
Recruitment Period: January 13, 2004 to October 25, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).
PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).
Surgical resection 4-6 weeks after completion of chemoradiotherapy
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).
PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).
Surgical resection 4-6 weeks after completion of chemoradiotherapy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
Baseline characteristics by cohort
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
n=58 Participants
FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid \& infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2 for 5 days) \& weekly oxaliplatin 45 mg/m\^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy
|
|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatmentThe complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
Outcome measures
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
n=58 Participants
FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid \& infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2 for 5 days) \& weekly oxaliplatin 45 mg/m\^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
|
|---|---|
|
Complete Pathologic Response Rate
|
14 percentage of participants
Interval 6.0 to 25.0
|
Adverse Events
5-Fluorouracil + Folinic Acid + Oxaliplatin
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
n=58 participants at risk
PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).
PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).
Surgical resection 4-6 weeks after completion of chemoradiotherapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
1/58 • Number of events 1 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Hemorrhage, GI-Stomach
|
6.9%
4/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Hyperbilrubinemia
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Nausea Vomiting
|
3.4%
2/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Dehydration
|
5.2%
3/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
GI Bleed
|
6.9%
4/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Jejunostomy tube placement (planned procedure)
|
1.7%
1/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
Other adverse events
| Measure |
5-Fluorouracil + Folinic Acid + Oxaliplatin
n=58 participants at risk
PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).
PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).
Surgical resection 4-6 weeks after completion of chemoradiotherapy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.8%
26/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.6%
5/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
24.1%
14/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
10.3%
6/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Increase ALT
|
10.3%
6/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Blood and lymphatic system disorders
Increase AST
|
12.1%
7/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
General disorders
Fatigue
|
72.4%
42/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.8%
19/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Nervous system disorders
Neuropathy
|
62.1%
36/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
69.0%
40/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
27.6%
16/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
53.4%
31/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
31.0%
18/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Dysphagaia
|
34.5%
20/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Reflux GERD
|
43.1%
25/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
72.4%
42/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
29.3%
17/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Eye disorders
Eyes red, Watery, Burning
|
24.1%
14/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
20.7%
12/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
5/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Nervous system disorders
Dizziness
|
19.0%
11/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
General disorders
Insomnia
|
50.0%
29/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hand, Foot, Skin
|
5.2%
3/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
8/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
6/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Nervous system disorders
Headache
|
13.8%
8/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Gastrointestinal disorders
J-tube pain
|
12.1%
7/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Substernal chest pain
|
5.2%
3/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
17.2%
10/58 • Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
|
Additional Information
Dr. Jaffer Ajani, MD / Professor, GI Medical Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place