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Chemoradiation and Panitumumab for Esophageal Cancer

Primary Purpose

Squamous Cell Carcinoma, Adenocarcinoma, Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
panitumumab
radiotherapy
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring chemoradiation, panitumumab, esophageal cancer, Resectable squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction
  • Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and CT scan of neck, thorax and abdomen.
  • T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible
  • Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm
  • If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible
  • No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
  • Non pregnant, non-lactating female patients, not planning to become pregnant within 6 months after the end of treatment.
  • Age ≥ 18 and ≤ 75
  • ECOG performance status 0 or 1
  • Adequate hematological, renal, hepatic and pulmonary functions
  • Written, voluntary informed consent
  • Patients must be accessible to follow up and management in the treatment center

Exclusion Criteria:

  • Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment
  • Pregnancy (positive serum pregnancy test) and lactation
  • Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
  • Previous chemotherapy, radiotherapy, treatment with an anti-EGFR antibody or with small molecule EGFR inhibitors
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization
  • Pulmonary fibrosis
  • Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
  • Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
  • Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  • Inadequate caloric- and/or fluid intake
  • Weight loss > 15%.

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carboplatin + paclitaxel + radiotherapy

Carboplatin+ paclitaxel+ panitumumab+ radiotherapy

Arm Description

Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.

Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy. Panitumumab panitumumab: 6mg/kg in weeks 1-3-5.

Outcomes

Primary Outcome Measures

Percentage of pathologic complete responses

Secondary Outcome Measures

R0 resection rate
Progression free survival
Toxicity profile

Full Information

First Posted
February 25, 2010
Last Updated
April 19, 2021
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT01077999
Brief Title
Chemoradiation and Panitumumab for Esophageal Cancer
Official Title
Chemoradiation Combined With Panitumumab Followed by Surgery for Patients With Operable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in the investigators trial the investigators will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.
Detailed Description
This is a Phase II, non-randomized trial. Eligible subjects will be treated with panitumumab plus carboplatin, paclitaxel and radiotherapy followed by surgical resection of the esophagus. Panitumumab administration schedule: Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, prior to administration of chemotherapy at a dose of 6 mg/kg on day 1, 15 and 29. If the first infusion is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. Chemotherapy regimen: Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29. Both drugs will be infused over one hour. Radiotherapy treatment: A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy. All patients will be radiated by external beam radiation, using 3-D conformal radiation technique. Surgery: Surgery will be performed preferably within 6 weeks after the completion of the chemoradiation and panitumumab. For carcinomas distal of the tracheal bifurcation but proximal to the gastro-esophageal junction, a transthoracic approach is preferred. For distal tumors involving the gastro-esophageal junction a transhiatal esophageal resection is preferred. A wide local excision including the N1 lymph nodes is carried out in both techniques including a standard excision of the lymph nodes around the coeliac axis. The continuity of the digestive tract will be restored by a gastric tube reconstruction or colonic interposition procedure with an anastomosis in the neck.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma, Adenocarcinoma, Esophageal Cancer, Gastro-esophageal Junction Cancer
Keywords
chemoradiation, panitumumab, esophageal cancer, Resectable squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin + paclitaxel + radiotherapy
Arm Type
Active Comparator
Arm Description
Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
Arm Title
Carboplatin+ paclitaxel+ panitumumab+ radiotherapy
Arm Type
Experimental
Arm Description
Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy. Panitumumab panitumumab: 6mg/kg in weeks 1-3-5.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC = 2 , weekly.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 50 mg/m2, weekly
Intervention Type
Drug
Intervention Name(s)
panitumumab
Other Intervention Name(s)
vectibix
Intervention Description
panitumumab: 6mg/kg in weeks 1-3-5.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
Primary Outcome Measure Information:
Title
Percentage of pathologic complete responses
Time Frame
6 weeks after the completion of the chemoradiation
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
the pathologist will determine the resection rate
Title
Progression free survival
Time Frame
Every 3 months during the first 2 years after surgery, and every 6 months thereafter.
Title
Toxicity profile
Time Frame
Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and CT scan of neck, thorax and abdomen. T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula Non pregnant, non-lactating female patients, not planning to become pregnant within 6 months after the end of treatment. Age ≥ 18 and ≤ 75 ECOG performance status 0 or 1 Adequate hematological, renal, hepatic and pulmonary functions Written, voluntary informed consent Patients must be accessible to follow up and management in the treatment center Exclusion Criteria: Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment Pregnancy (positive serum pregnancy test) and lactation Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment Previous chemotherapy, radiotherapy, treatment with an anti-EGFR antibody or with small molecule EGFR inhibitors Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization Pulmonary fibrosis Pre-existing motor or sensory neurotoxicity greater than WHO grade 1 Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. Dementia or altered mental status that would prohibit the understanding and giving of informed consent Inadequate caloric- and/or fluid intake Weight loss > 15%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanneke Wilmink, MD PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

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Chemoradiation and Panitumumab for Esophageal Cancer

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