The aim of this study is to evaluate whether intensive treatment of gastric and esophageal cancer with limited metastases can lead to a better survival. We also want to evaluate whether factors can be found that can predict which patients will…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
progression free survival
Secondary outcome
-safety
-quality of life
- overall survival
- whether ctDNA can help us better select the right patients in the future who
will benefit from this treatment
Background summary
In previous research it seems that a more intensive treatment of gastric or
esophageal cancer, including limited metastases, can lead to a better survival.
However, these previous studies were done in small patient groups, which were
very different from each other. Therefore, it is currently unclear whether 1)
this more intensive treatment has real added value and 2) which patients can
benefit from this treatment and who cannot. Through this research, we want to
see whether we can find a group of patients who would benefit from this by
mapping various tumor characteristics, as well as blood values.
Study objective
The aim of this study is to evaluate whether intensive treatment of gastric and
esophageal cancer with limited metastases can lead to a better survival. We
also want to evaluate whether factors can be found that can predict which
patients will benefit from this more intensive treatment before starting
treatment. At present, the standard treatment in the Netherlands for metastatic
gastric and esophageal cancer consists of chemotherapy with the aim of
alleviating any symptoms and, if possible, prolonging life. In this study, we
want to evaluate whether, in addition to chemotherapy, the removal of the
gastric or esophageal cancer, including the metastases, leads to a longer
survival than if only chemotherapy were given.
Study design
The first step is chemotherapy treatment. This is the standard treatment for
people with metastatic esophageal and stomach cancer in the Netherlands. Which
chemotherapy is determined by the internist-oncologist. During and after
chemotherapy, scans are performed to check whether the cancer has not grown
despite chemotherapy:
- If the cancer has grown, the study will end for those patients.
- If the disease has remained the same or has decreased after chemotherapy, the
following steps will be followed
In case of stomach cancer:
- After a waiting period of at least 6 weeks during which no new metastases are
seen on scans, it will remove the stomach cancer as well as the metastases.
- To remove the stomach cancer, an operation will take place in which all or
part of the stomach (depending on the location of the cancer) is removed.
- There are different ways of treatment for removing the metastases. The choice
depends, among other things, on where the metastasis is located. If several
methods are possible, the least intrusive method will be chosen. The treatment
options from which you can choose are: radiation (radiotherapy), ablation
(puncturing the metastasis with a thin radiofrequency needle with which the
metastasis can be heated and killed) or surgery.
- The order in which the gastric cancer or metastases are treated depends on
the methods of treatment.
In case of esophageal cancer:
- approximately 6 weeks after chemotherapy, treatment for the esophageal cancer
will be started if no new metastases are visible on scans. This treatment
consists of a combination of radiation and chemotherapy (chemoradiation).
- After a waiting period of about 6 weeks after the end of the chemoradiation,
the metastases and esophageal cancer are examined again.
- If no new metastases have arisen during the time of the above treatment, a
visual examination of the esophagus will be used to determine whether there is
still cancer in the esophagus after radiotherapy.
- If there is no more cancer in the esophagus, the metastases will be removed.
There are various ways of treatment available to remove the metastases. The
choice depends, among other things, on where the metastasis is located. If
several methods are possible, the least intrusive method will be chosen. The
treatment options from which you can choose are: radiation (radiotherapy),
ablation (puncturing the metastasis with a thin radiofrequency needle with
which the metastasis can be heated and killed) or surgery.
- If there is still cancer in the esophagus, surgery will be performed to
remove the esophageal cancer. In addition, the metastases are removed, as
explained above.
- The order in which the treatment of the gastric cancer or the metastases take
place depends on the methods of treatment.
Study burden and risks
In this study, patients initially receive the standard treatment, namely
palliative chemotherapy. Only in the case of a good response are patients
eligible for local treatment of the primary tumor and metastases. The
additional burden and risks of this study are therefore in this phase of
treatment. These are the standard risks associated with surgery on the
esophagus or stomach and treatment of the metastases.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• histologically proven cT2-4aN0-2 adenocarcinoma carcinoma of the oesophagus,
gastroesophageal junction or stomach.
• histologically proven metastases from esophageal or gastric cancer or if
histologic biopsy is not possible, radiological images are highly suspicious
for metastases
• Maximum of 3 metastases in one organ OR M1 lymph node metastasis restricted
to one region (brain metastases are allowed)
• Resectable primary tumor.
• Metastases eligible for adequate local treatment.
• good performance status (WHO performance status 0-2) (appendix I).
• ASA 1-2 (appendix II).
• written informed consent.
• age >= 18
• fit to receive palliative systemic treatment
Exclusion criteria
• pregnancy, lactating female
• peritoneal metastases or positive cytology from abdominal washings.
• patients participating in other trials that would interfere with the
implementation of this protocol.
• Patients with N3M1 disease
• Unable or unwilling to undergo systemic palliative treatment
Design
Recruitment
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 |
|---|---|
| CCMO | NL78680.031.21 |