To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases in level III and/ or…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the percentage of overall postoperative complications grade
3b and higher as stated by the modified Clavien-Dindo classification (MCDC).
Secondary outcome
Secondary outcomes are individual components of the primary outcome,
complications grade 2 and 3a, mortality, operation related events and
postoperative recovery including quality of life, disease free survival, 5 year
overall survival and if applicable location of recurrent disease.
Background summary
There is no world wide consensus on the oncological benefit versus increased
morbidity associated with three field lymphadenectomy in patients with
esophageal cancer and cervical lymph node metastases. In Asian countries,
esophagectomy is commonly combined with a three field lymphadenectomy,
including resection of cervical, thoracic and abdominal lymph nodes. However,
in Western countries patients with cervical lymph node metastases are generally
precluded from curative treatment.
Study objective
To assess the safety and feasibility of curative esophagectomy combined with
three field lymphadenectomy after chemo-radiation in Western patients with
resectable thoracic esophageal carcinoma and cervical lymph node metastases in
level III and/ or IV of the neck. Secondary objective is to determine the
effect on survival and recurrence.
Study design
Mono centre prospective fase II single-arm feasibility trial.
Intervention
Transthoracic esophageal resection combined with three field lymphadenectomy.
Study burden and risks
The additional burden for the patient consists of an esophagectomy combined
with three field lymph node dissection including thoracic, abdominal, and
bilateral cervial level III, and IV lymph node dissection. Pre-operative
evaluation will be performed according to general practice. Postoperative care
and outpatient visits do not differ from regular protocol. The study is
associated with a mediate risk classification. As there is a potential survival
benefit, we consider the additional burden and risks justified. This study is
designed as a one group study, which eliminates group relatedness.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Histologically proven squamous cell carcinoma or adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
- Surgical resectable carcinoma (T1-4a, N1-3)
- Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
- Age >= 18
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent
Exclusion criteria
- Distant metastases
- Esophageal carcinoma < 3 cm beneath UES
- Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
- Former radiotherapy or chemotherapy for esophageal carcinoma
- Former radiotherapy precluding radiotherapy according the CROSS protocol
- Inadequate pulmonary function disabling transthoracic resection
- Previous neck dissection
- New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02426879 |
| CCMO | NL48231.041.14 |
| OMON | NL-OMON24304 |