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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00042668 | Other Identifier | JHMIRB | |
| R33CA127055 | U.S. NIH Grant/Contract | View source |
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Study stopped due to early stopping rule
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.
Primary Objectives
• To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy |
|
| Arm B | Active Comparator | Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
|
| Arm C | Active Comparator | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response | CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall survival with given treatment strategy. | 3 years |
| Time to Disease Progression | To determine time to disease progression with this treatment strategy. |
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Inclusion Criteria:
Histologically confirmed adenocarcinoma of the esophagus or GE junction
Patient must be untreated with chemotherapy, radiation therapy, or surgery for this diagnosis of esophageal cancer. (Endoscopy with biopsy and dilation is permitted.)
Tumor must be located between 20 cm from the teeth endoscopically and 2 cm into the gastric cardia. Cervical esophageal cancers and true gastric cancers are excluded.
Stage T2-3/N0-3/M0 as determined by imaging studies and biopsy where appropriate. T4 disease is permitted if defined as resectable by the thoracic surgeon (involvement of the pleura, pericardium or diaphragm).
Patients must have had an endoscopic ultrasound
Patients must have had a staging PET scan
Age ≥ 18 and ≤ 75
ECOG performance status 0-1.
Surgically resectable tumor
Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds three years.
Patients must have adequate organ and marrow function as defined below:
Female patients must not be pregnant or breast feeding. Radiotherapy is associated with significant birth defects and/or non-viable fetus. Paclitaxel, cisplatin, oxaliplatin, and 5-fluorouracil have teratogenic potential. A negative pregnancy test is required within 14 days of treatment for all women of childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately.
Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronan Kelly, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronan Kelly, M.D. | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). |
| FG001 | Arm B | Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29. 5-Fu: Oxaliplatin & 5-fu:
Cisplatin/5-fluorouracil:
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. |
| FG002 | Cisplatin With 5 Fu | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathological Complete Response | CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma. | Posted | Count of Participants | Participants | 3 years |
|
Up to 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronan Kelly, MD | SKCCC | 443-287-0005 | rkelly25@jhmi.edu |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Cisplatin | Drug | Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
|
|
|
| Oxaliplatin | Drug | Oxaliplatin 85 mg/m2 days 1, 15, 29. |
|
|
| 5-Fluorouracil | Drug | Oxaliplatin and 5-fluorouracil:
Cisplatin and 5-fluorouracil:
|
|
|
| Radiotherapy | Radiation | Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. |
|
|
| Esophagectomy | Procedure | The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). |
|
|
| 3 years |
| Esophageal Tumor CHFR Methylation and Detection in Plasma | To determine the agreement between tumor CHFR methylation and detection in plasma. | 3 years |
| BG001 | Arm B | Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29. 5-Fu: Oxaliplatin & 5-fu:
Cisplatin/5-fluorouracil:
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. |
| BG002 | Arm C | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm B | Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29. 5-Fu: Oxaliplatin & 5-fu:
Cisplatin/5-fluorouracil:
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. |
| OG002 | Arm C | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
|
|
| Secondary | Survival | Overall survival with given treatment strategy. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Time to Disease Progression | To determine time to disease progression with this treatment strategy. | Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure. | Posted | 3 years |
|
|
| Secondary | Esophageal Tumor CHFR Methylation and Detection in Plasma | To determine the agreement between tumor CHFR methylation and detection in plasma. | Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure. | Posted | 3 years |
|
|
| 7 |
| 13 |
| 4 |
| 13 |
| 4 |
| 13 |
| EG001 | Arm B | Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Cisplatin: Paclitaxel and cisplatin:
Cisplatin and 5-fluorouracil:
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29. 5-Fu: Oxaliplatin & 5-fu:
Cisplatin/5-fluorouracil:
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. | 4 | 9 | 6 | 9 | 1 | 9 |
| EG002 | Arm C | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy | 3 | 9 | 5 | 9 | 7 | 9 |
| Dehydration | General disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Atrial Fibrliation | Cardiac disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Failure to thrive | General disorders | Non-systematic Assessment |
|
| Non-responsive | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neutropenic Fever | General disorders | Non-systematic Assessment |
|
| Orthostatic | Cardiac disorders | Non-systematic Assessment |
|
| Syncope | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | Non-systematic Assessment |
|
| Thrombus | General disorders | Non-systematic Assessment |
|
| Low Potassium | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Anorexia | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Renal Calculi | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |