Objective of the study is to investigate if a mild sensitizing drug (oral capecitabine) combined with a high dose hypofractionated radiation regime to the esophageal region is feasible in this unfit patient group. If feasible, in a consecutive study…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
feasibility of this regime (grade 3 toxicity and compliance)
Secondary outcome
locoregional control and survival
Background summary
Technically irresectable or medically inoperable patients in a curable stage
of disease of esophageal cancer are referred for curatively intended
chemoradiation. The standard chemoradiation schedule consists of 50,4 Gy with
6x weekly Carboplatin and Paclitaxel. This schedule has a curative intent
(3-years OS = 40%) but leads to grade III toxicity in about one third of the
patients, with an excess in toxicity in older patients. This standard CRT
regime is often considered too heavy for old or unfit patients. For patients
considered not eligible for the standard chemoradiation, a palliative
radiotherapy only schedule remains. The Dutch national radiation guideline
suggests for unfit patients a high dose hypo fractionated scheme of 50 Gy in 16
fractions, which is considered feasible in this patient group. However,
radiation only for esophageal cancer should be considered as palliative. The
combination of radiation with sensitizing chemotherapy has proven to change the
intend from palliative to curative. Capecitabine, an oral drug which
metabolizes in the body to the active drug 5-FU, is a well-known
radiosensitzer, with a mild toxicity profile, which can be adapted quickly and
easy according to the encountered toxicity.
Study objective
Objective of the study is to investigate if a mild sensitizing drug (oral
capecitabine) combined with a high dose hypofractionated radiation regime to
the esophageal region is feasible in this unfit patient group. If feasible, in
a consecutive study the the added value of capecitabine to the standard
radiotherapy will be investigated with locoregional tumorcontrol as primairy
endpoint and survival as secondary endpoint.
Study design
Observational study radiotherapy of 16 fractions of 3.125 Gy radiotherapy
combined with twice daily oral capecitabine 825 mg\m2.
Intervention
addition of capecitabine twice daily to the standard radiotherapy
Study burden and risks
The burden of participation is considered small since it only consists of twice
daily intake of tablets. The risk of toxicity can be an excess in fatique,
diarrhoea, swallowing pain and hematological disturbances, but is considered
small since this schedule is part of standard treatment in patients with
bladder cancer and rectal cancer, with acceptable toxicity and good compliance.
De Boelelaan 1117 De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117 De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 years or older - WHO performance score 0-3 - Biopsy proven
carcinoma of the esophagus - cT1-T4aN0-3M0, including patients with M1 disease
based on pathologic nodes at supraclavicular or truncus coeliacus level - The
multidisciplinary team rejects surgical treatment - The radiation oncologist
and medical oncologist consider patient not eligible for the standard
chemoradiation, with at least one of the following characteristics: WHO
performance 3, age of > 80 year, metabolic disorders excluding Carboplatin or
Paclitaxel, mainly wheelchair bounded, evidence of interstitial lung disease or
active, non-infectious pneumonitis, or a Charlson index of 3 or more.
Exclusion criteria
- Previous irradiation overlapping with the intend fields
- Stent in situ
- Serum DPD deficiency
- Prior intravenous chemotherapy for esophageal cancer
- An active infection requiring systemic therapy
- Has known psychiatric disorders or substance abuse disorders that would
interfere with cooperation in the trial
- Inability, or serious suspicion of inability to administer the prescribed
doses of capecitabine
- Is pregnant or breast feeding
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-006164-85-NL |
| CCMO | NL75846.029.21 |