Possibly, outcomes of treatment can be further improved by adding atezolizumab to neoadjuvant chemoradiation. As a first step we aim to know whether the addition of atezolizumab feasible. That is, we want to know how the treatment is tolerated and…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is feasibility defined as percentage completion of
treatment with atezolizumab. Patients that do not complete treatment with
atezolizumab for reasons other than toxicity will be replaced and not included
in the analysis of the primary end point.
Secondary outcome
Secondary endpoints are:
• Incidence and severity of toxicity defined according to CTCAE v4.03 and
Radiation Oncology Group (RTOG) criteria.
• Percentage completion of chemotherapy and radiation treatment
• Percentage withdrawal rate from surgery
• Incidence and severity of post-operative complications according to the Dindo
classification.
• Pathological response according to the Mandard criteria.
• R0 resection rate.
• Progression free survival
• Overall survival
Exploratory endpoints are:
• Potential biomarker development based on assessment of tumour biopsies,
faeces and blood samples and the proposed mechanism of action of study
drugs.
Background summary
The prognosis of esophageal cancer is poor, despite treatment with
chemoradiation and resection. The outcome of the treatment may be improved by
the addition of certain forms of immunotherapy, such as atezolizumab, to the
treatment. In this study we investigate whether it is feasible.
Study objective
Possibly, outcomes of treatment can be further improved by adding atezolizumab
to neoadjuvant chemoradiation. As a first step we aim to know whether the
addition of atezolizumab feasible. That is, we want to know how the treatment
is tolerated and whether the treatment can be given as scheduled.
Study design
This is a non-randomized feasibility study on the combination of atezolizumab
in combination with carboplatin, paclitaxel, and radiation therapy, followed by
a resection of the primary tumor.
Intervention
Atezolizumab is added once every three weeks to the standard chemoradation.
After 5 administrations surgery takes place.
Study burden and risks
The administration of atezolizumab prolongs the first visit by ~ 90 minutes;
then per administration ~ 60 minutes extra are required. (In total 5
administrations)
In rare cases, both taking of blood samples as well the insertion of an
infusion needle may be painful.
The extra gastroduodenoscopy can result in bleeding ora perforation may result.
Finally, a patient can have side effects of the study medication. The most
common side effects atezolizumab include fatigue, nausea, decreased appetite,
diarrhea, constipation and cough. Because by atezolizumab the immune system is
enhanced, specific side effects can occur which have to do with an immune
response directed against one's own body. This can manifest itself as an
inflammation of the liver, lungs, intestines, pancreas, brains or meninges. It
is also possible that the patient is developing diabetes, a too slow or too
fast-acting thyroid or adrenal insufficiency. Finally, specific neurological
syndromes (Guillain-Barré syndrome, myasthenia gravis) may develop.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Histologically proven adenocarcinoma of the esophagus or gastro esophageal
junc
2. The tumor is surgically resectable
3. Patient is fit for surgery
Exclusion criteria
Past or current history of malignancy other than entry diagnosis interfering
with prognosis of esophageal cancer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-004744-11-NL |
| CCMO | NL60011.018.16 |