The present study is intended to prospectively evaluate the validity of PET/CT with regard to target volume definition by assessing the incidence of locoregional recurrences outside the CTV among patients with esophageal cancer.The hypothesis to be…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In what proportion of patients with a locoregional recurrence, observed at 6,
12 or 18 months after treatment, do recurrences occur outside the PET/CT-based
CTV and can be considered as unpreventable?
Secondary outcome
not applicable
Background summary
This study will provide information on the additional value of FDG-PET in the
radiotherapy treatment planning of patients with esophageal cancinoma.
(combined chemo-)radiotherapy is increasingly applied in ther treatment of
patients with cancer of the esophagus or gastroesophageal junction (GEJ),
either as definitive therapy or prior to a curative intended surgical
resection. Despite this treatment, however, locoregional recurrent disease
remains the main factor limiting survival.
More accurate delineation of the tumor area may be achieved using PET/CT
instead of CT alone. Application of PET/CT in target volume definition may
result in better dose coverage of the tumor volume, thereby inproving
locoregional tumor control an, consequently, survival of patients.
Some preliminary studies suggest that the use of PET/CT in the treatment
planning phase may be useful. However, in none of these studies, treatment
outcome was assessed. Therefore, the current data do not provide sufficient
evidence for the validation of integrated planning-PET/CT with regard to the
incidence of locoregional recurrences outside the PET/CT defined Clinical
Target Volume (CTV).
The present study is intended to prospectively evaluate the validity of PET/CT
with regard to target volume definition by assessing the incidence of
locoregional recurrences outside the CTV among patients with esophageal cancer.
Study objective
The present study is intended to prospectively evaluate the validity of PET/CT
with regard to target volume definition by assessing the incidence of
locoregional recurrences outside the CTV among patients with esophageal cancer.
The hypothesis to be tested is that the use of co-registered planning-PET/CT
will result in a low incidence of locoregional recurrences outside the CTV.
Study design
This is a prospective cohort study testing the hypothesis that in less than 5%
of the patients, locoregional recurrence, observed at 6, 12 or 18 months after
treatment, will occur outside the PET/CT-based CTV.
Patients eligible for the study will undergo definitive radiotherapy with or
without concomitant chemotherapy with planning-PET/CT based target volumes,
either or not followed by surgery. Routine follow up will be carried out every
6 months, using CT. In case of (suspicion of) locoregional recurrence, EUS
analysis and PET/CT-based recurrence analysis should be carried out with
comparison and co-registration of PET/CT-based target volumes.
After neoadjuvant chemoradiation the response on this therapy will be analysed
in situ before the removal of the esophageal specimen. In case of residual
tumor, comparison with the irradiated volume needs to be carried out.
Futher, the follow up in this group is carried out the same way as described
above.
Study burden and risks
No specific burden except for three additional CT during the follow up at 6, 12
and 18 months.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
-histological documented cancer of the esophagus or gastroesophageale junction (GEJ)
- locally curable disease without distant metastases (M1b excluded)
planned for high dose radiotherapy with or without chemotherapy
- no previous or concurrent malignancy (except for basal cell ca. of the skin or in situ ca. of the cervix or superficial bladder ca. (pTa) in the past five years.
- previously untreated patients (except induction chemotherapy)
- no evidence of serious active infections
- age >= 18 years
- written informed consent to participate in the study
- patients must have an WHO performance status 0-2
- all patients must be evaluated by a radiation oncologist prior to enrollment to ensure that the patient is an appropriate candidate for radiation therapy.
Exclusion criteria
- known distant metastases
- previous or concurrent malignancy (except for basal cell ca. of the skin or in situ ca. of the cervix or superficial bladder ca. (pTa) in the past five years
- prior chest or upper abdominal radiotherapy, prior systemic chemotherapy, or prior esophageal or gastric surgery.
- evidence of serious active infections
- dementia or altered mental status that would prohibit the understanding and giving of informed consent
-pregnant or lactating women. sexually active patients of childbearing potential must implement effective contraceptive practices during the study while in this study
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 | NL25994.042.08 |