Trial Outcomes & Findings for Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery (NCT NCT00268437)
NCT ID: NCT00268437
Last Updated: 2016-07-06
Results Overview
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline to time of surgery (around 10 - 18 weeks post-baseline)
Results posted on
2016-07-06
Participant Flow
This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Due to early closure not all the endpoints were analyzed.
Participant milestones
| Measure |
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery
|
|---|---|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Pemetrexed/Carboplatin
n=27 Participants
Pemetrexed+Carboplatin+Radiation\>
\> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.\>
\> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.\>
\> conventional surgery\>
\> neoadjuvant therapy\>
\> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
|
|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to time of surgery (around 10 - 18 weeks post-baseline)The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=26 Participants
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
conventional surgery
|
|---|---|
|
Pathologic Complete Response Rate
|
23 percentage of participants
Interval 9.0 to 44.0
|
SECONDARY outcome
Timeframe: From baseline to 4 yearsTime from registration to death due to any cause.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=26 Participants
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
conventional surgery
|
|---|---|
|
Overall Survival
|
17.8 months
Interval 12.2 to 30.7
|
Adverse Events
Pemetrexed/Carboplatin
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed/Carboplatin
n=27 participants at risk
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal fistula
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Platelet count decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed/Carboplatin
n=27 participants at risk
Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
92.6%
25/27 • Number of events 59
|
|
Cardiac disorders
Atrial fibrillation
|
7.4%
2/27 • Number of events 2
|
|
Cardiac disorders
Myocardial ischemia
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
40.7%
11/27 • Number of events 15
|
|
Gastrointestinal disorders
Dysphagia
|
74.1%
20/27 • Number of events 48
|
|
Gastrointestinal disorders
Esophageal mucositis
|
25.9%
7/27 • Number of events 10
|
|
Gastrointestinal disorders
Esophageal pain
|
40.7%
11/27 • Number of events 21
|
|
Gastrointestinal disorders
Esophagitis
|
59.3%
16/27 • Number of events 30
|
|
Gastrointestinal disorders
Nausea
|
70.4%
19/27 • Number of events 36
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
25.9%
7/27 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
9/27 • Number of events 12
|
|
General disorders
Death NOS
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Edema limbs
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Fatigue
|
29.6%
8/27 • Number of events 12
|
|
Infections and infestations
Endocarditis infective
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Small intestine infection
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Wound infection
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
1/27 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
29.6%
8/27 • Number of events 9
|
|
Investigations
Blood bilirubin increased
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
88.9%
24/27 • Number of events 43
|
|
Investigations
Lymphocyte count decreased
|
3.7%
1/27 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
85.2%
23/27 • Number of events 37
|
|
Investigations
Platelet count decreased
|
85.2%
23/27 • Number of events 47
|
|
Investigations
Weight loss
|
7.4%
2/27 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
14.8%
4/27 • Number of events 8
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
2/27 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
1/27 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
3/27 • Number of events 8
|
|
Psychiatric disorders
Depression
|
18.5%
5/27 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
7.4%
2/27 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.6%
8/27 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.4%
2/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
3/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
37.0%
10/27 • Number of events 12
|
|
Vascular disorders
Hypotension
|
25.9%
7/27 • Number of events 10
|
|
Vascular disorders
Thrombosis
|
7.4%
2/27 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place