NCT01077999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

February 25, 2010

Last Update Submit

April 19, 2021

Conditions

Squamous Cell CarcinomaAdenocarcinomaEsophageal CancerGastro-esophageal Junction Cancer

Keywords

chemoradiationpanitumumabesophageal cancerResectable squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction

Outcome Measures

Primary Outcomes (1)

  • Percentage of pathologic complete responses

    6 weeks after the completion of the chemoradiation

Secondary Outcomes (3)

  • R0 resection rate

    the pathologist will determine the resection rate

  • Progression free survival

    Every 3 months during the first 2 years after surgery, and every 6 months thereafter.

  • Toxicity profile

    Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter.

Study Arms (2)

Carboplatin + paclitaxel + radiotherapy

ACTIVE COMPARATOR

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.

Drug: CarboplatinDrug: PaclitaxelRadiation: radiotherapy

Carboplatin+ paclitaxel+ panitumumab+ radiotherapy

EXPERIMENTAL

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.

Drug: CarboplatinDrug: PaclitaxelDrug: panitumumabRadiation: radiotherapy

Interventions

CarboplatinDRUG

Carboplatin AUC = 2 , weekly.

Carboplatin + paclitaxel + radiotherapyCarboplatin+ paclitaxel+ panitumumab+ radiotherapy
PaclitaxelDRUG

Paclitaxel 50 mg/m2, weekly

Carboplatin + paclitaxel + radiotherapyCarboplatin+ paclitaxel+ panitumumab+ radiotherapy
panitumumabDRUG

panitumumab: 6mg/kg in weeks 1-3-5.

Also known as: vectibix
Carboplatin+ paclitaxel+ panitumumab+ radiotherapy
radiotherapyRADIATION

A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.

Carboplatin + paclitaxel + radiotherapyCarboplatin+ paclitaxel+ panitumumab+ radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Squamous CellAdenocarcinomaEsophageal Neoplasms

Interventions

CarboplatinPaclitaxelPanitumumabRadiotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeutics

Study Officials

  • Hanneke Wilmink, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 2, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2012

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

NL(1)