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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Lund University Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Region Ćrebro County |
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This study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resective surgery after 4-6 weeks | Active Comparator | Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT) |
|
| Resective surgery after 10-12 weeks | Active Comparator | Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resective surgery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete histological response proportion, using the Chirieac grading system. | analysis is completed 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall primary tumor treatment response defined as complete histological response (Chirieac 0) and partial histological response (Chirieac 1 and 2) together. | analysis is completed 4 weeks after surgery | |
| ypN tumor status, classified as ypN0 to ypN3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Nilsson, Prof | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery Gastrocentrum Karolinska Univeristy Hospital | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32833767 | Derived | Nilsson K, Klevebro F, Rouvelas I, Lindblad M, Szabo E, Halldestam I, Smedh U, Wallner B, Johansson J, Johnsen G, Aahlin EK, Johannessen HO, Hjortland GO, Bartella I, Schroder W, Bruns C, Nilsson M. Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer. Ann Surg. 2020 Nov;272(5):684-689. doi: 10.1097/SLA.0000000000004340. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D000230 | Adenocarcinoma |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| University Hospital, UmeƄ | OTHER |
| St. Olavs Hospital | OTHER |
| University Hospital, Linkoeping | OTHER |
| University Hospital of North Norway | OTHER |
| University Hospital Cologne | UNKNOWN |
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| analysis is completed 4 weeks after surgery |
| 5 year survival by intention to treat and per protocol analyses in each study arm. | 5 years |
| Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm. | 5 years |
| R0 resection rate in each study arm. | analysis is completed 4 weeks after surgery |
| Resectability rate in each study arm. | 4-6 or 10-12 weeks after completed CRT |
| Safety and toxicity (only grade 3-5 toxicity will be reported) ety and toxicity (only grade 3-5 toxicity will be reported) | According to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 | 4-6 or 10-12 weeks after completed CRT |
| Postoperative complications in each study arm. | Using the classification in the Swedish National Registry for Gastric and Esopgageal Cancer (NREV), including Clavien-Dindo classification. | 30 days after surgery |
| Health-related quality of life (HRQOL). | Validated questionnaires that assess patients functions (physical, emotional, social, role and cognitive function), symptoms (e.g. fatique, pain, nausea/vomiting, appetite, dysphagia, eating difficulties and diarrhea) and global quality of life. | 4-6 or 10-12 weeks prior to surgery (at randomization after completed CRT), within a week before surgery, 6 months postoperatively, 12 months postoperatively and then yearly until 5 years of follow-up. |
| QUALYs at 5 year follow-up in each study arm. | Quality Adjusted Life Year assesses not only how much longer the treatment will allow the patient to live, but weighs in the quality of life with survival as a composite variable. | 5 years after surgery |
| Correlation between symptom scores, endoscopy and radiology; and complete histological response. | 4 weeks after surgery |
| Nutritional status of patients in each study arm. | within a week before the start of CRT, within a week before surgery and 5 years after surgery |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |