|- candidate number||10321|
|- NTR Number||NTR3060|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-sep-2011|
|- Secondary IDs||11_019 METC AMC|
|- Public Title||T4 Oesophageal Resection.|
|- Scientific Title||Chemoradiation followed by surgery for patients with cT4 oesophageal carcinoma.|
|- hypothesis||Patients with T4-irresectable carcinoma are generally treated with definitive chemoradiotherapy without curative intent. Considering the positive results of neoadjuvant chemotherapy followed by surgery, we hypothesize that chemoradiotherapy can reduce the size of T4 tumors and allows for surgical resection of the esophagus and an improved survival rate. |
|- Healt Condition(s) or Problem(s) studied||Esophageal cancer, Oesophagectomy, Chemoradiotherapy, T4 tumor|
|- Inclusion criteria||1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction;|
2. Surgically irresectable T4 carcinoma as determined by endoscopic ultrasonography (EUS), CT scan or PET-CT of neck, thorax and abdomen, without distant mestastases.
|- Exclusion criteria||1. cT4 carcinoma with tracheobronchial involvement demonstrated on bronchoscopy after chemoradiotherapy;|
2. Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment;
3. Pregnancy (positive serum pregnancy test) and lactation;
4. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <1 year before enrollment;
5. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment;
6. Dementia or altered mental status that would prohibit the understanding and giving of informed consent;
7. Inadequate caloric and/or fluid intake
Weight loss >15%.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||6-jul-2011|
|- planned closingdate||1-feb-2013|
|- Target number of participants||30|
|- Interventions||Surgery after chemoradiotherapy: Transthoracic esophagal resection (open, right thoracotomy) with en-bloc two-field lymphadenectomy.|
|- Primary outcome||The ability to achieve a radical (R0) resection.|
|- Secondary outcome||1. Toxicity profile of chemoradiotherapy;|
2. Adequacy of PET-CT and EUS in (re)staging T4 esophageal carcinoma;
3. Peri-operative morbidity and mortality;
4. Percentage of pathologic complete response;
5. Progression free survival at 6 months.
|- Timepoints||Patients will fill out questionnaires regarding quality of life on 6 occasions; prior to chemoradiotherapy, prior to surgery, 6 weeks postoperatively and 3, 6, 12 months after surgery. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| R.L.G.M. Blom|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.I. Berge Henegouwen, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Surgery|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Rationale:|
Current treatment of cT4 (locally irresectable) esophageal carcinoma is subject of debate, but mostly consists of chemoradiotherapy (CRT). However, the results of definite CRT in cT4 esopahgeal carcinoma remain poor with only 20% of patients alive at 3 years after start of CRT and a local recurrence rate up to 60% without any curative options and with an infaust prognosis.
Local control and survival might be improved by surgical resection following CRT for cT4 esophageal carcinoma. Only small series concerning this topic exist at present time, suggesting feasibility and improved local control.
To assess the feasibility of surgery following CRT in patients with cT4 esophageal carcinoma with regard to morbidity, mortality and the possibility to achieve a R0 resection.
Phase II, non-randomized trial.
Patients with cT4 irresectable esophageal carcinoma (adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma) of the intrathoracic esophagus or gastroesophageal junction, aged >18 <75 years.
Esophagectomy after chemoradiotherapy.
The ability to achieve a radical (R0) resection. Secondary endpoint are toxicity profile, adequacy of PET-CT and EUS in (re-)staging T4 esophageal carcinoma, perioperative morbidity and mortality, percentage of pathologic complete response, progression free survival at 6 months.
|- Main changes (audit trail)|
|- RECORD||6-sep-2011 - 25-sep-2011|