Trial Outcomes & Findings for Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma (NCT NCT00525915)

Last Updated: 2015-02-09

Results Overview

Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) \<50% of residual cells in the surgical specimen; or 3) \>50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

Surgery post chemotherapy (approximately 10-11 weeks)

Results posted on

2015-02-09

Participant Flow

Recruitment Period: April 01, 2005 to June 20, 2011. All recruitment done at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Arm A: Chemo With Radiation Treatment For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.	Arm B: Pre-Op Chemo + Chemo With Radiation Treatment Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
Overall Study STARTED	63	63
Overall Study COMPLETED	55	54
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Chemo With Radiation Treatment For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.	Arm B: Pre-Op Chemo + Chemo With Radiation Treatment Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
Overall Study Non-Compliance	0	1
Overall Study Disease Progression	5	6
Overall Study Withdrawal by Subject	1	0
Overall Study Refused Surgery	1	2
Overall Study Unrelated illness	1	0

Baseline Characteristics

Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Chemo With Radiation Treatment n=63 Participants For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.	Arm B: Pre-Op Chemo + Chemo With Radiation Treatment n=63 Participants Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)	Total n=126 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	59 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	63 Participants n=7 Participants	124 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	63 participants n=7 Participants	126 participants n=5 Participants

PRIMARY outcome

Timeframe: Surgery post chemotherapy (approximately 10-11 weeks)

Population: Participants who had surgery were reported for the pathCR rate assessment in this outcome.

Outcome measures

Outcome measures
Measure	Arm A: Chemo With Radiation Treatment n=55 Participants For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.	Arm B: Pre-Op Chemo + Chemo With Radiation Treatment n=54 Participants Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
Pathologic Complete Response Rate	13 percentage of participants	26 percentage of participants

Adverse Events

Arm A: Chemo With Radiation Treatment

Serious events: 10 serious events

Other events: 63 other events

Deaths: 0 deaths

Arm B: Pre-Op Chemo + Chemo With Radiation Treatment

Serious events: 7 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Chemo With Radiation Treatment n=63 participants at risk For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.	Arm B: Pre-Op Chemo + Chemo With Radiation Treatment n=63 participants at risk Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
Gastrointestinal disorders DEHYDRATION	3.2% 2/63 • Number of events 2 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Gastrointestinal disorders NAUSEA/VOMITING	4.8% 3/63 • Number of events 3 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Investigations FEVER	3.2% 2/63 • Number of events 2 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Gastrointestinal disorders Gastrointestinal (GI) BLEED	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	3.2% 2/63 • Number of events 2 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Cardiac disorders ATRIAL FIBRILLATION	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	3.2% 2/63 • Number of events 2 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Respiratory, thoracic and mediastinal disorders DYSPHAGIA	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Respiratory, thoracic and mediastinal disorders DYSPNEA	3.2% 2/63 • Number of events 2 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Infections and infestations CELLULITIS	0.00% 0/63 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.	1.6% 1/63 • Number of events 1 • Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.

Other adverse events

Additional Information

Jaffer Ajani, MD / Professor, GI Medical Oncology

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