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Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer (NeoResII)

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ClinicalTrials.gov Identifier: NCT02415101
Recruitment Status : Active, not recruiting
First Posted : April 14, 2015
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Oslo University Hospital
Haukeland University Hospital
St. Olavs Hospital
Lund University Hospital
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Region Örebro County
University Hospital, Umeå
Information provided by (Responsible Party):
Magnus Nilsson, Karolinska University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of the Esophagus Procedure: Resective surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia
Study Start Date : February 2015
Actual Primary Completion Date : April 19, 2019
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resective surgery after 4-6 weeks
Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT)
Procedure: Resective surgery
Active Comparator: Resective surgery after 10-12 weeks
Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT)
Procedure: Resective surgery



Primary Outcome Measures :
  1. Complete histological response proportion, using the Chirieac grading system. [ Time Frame: analysis is completed 4 weeks after surgery ]

Secondary Outcome Measures :
  1. Overall primary tumor treatment response defined as complete histological response (Chirieac 0) and partial histological response (Chirieac 1 and 2) together. [ Time Frame: analysis is completed 4 weeks after surgery ]
  2. ypN tumor status, classified as ypN0 to ypN3. [ Time Frame: analysis is completed 4 weeks after surgery ]
  3. 5 year survival by intention to treat and per protocol analyses in each study arm. [ Time Frame: 5 years ]
  4. Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm. [ Time Frame: 5 years ]
  5. R0 resection rate in each study arm. [ Time Frame: analysis is completed 4 weeks after surgery ]
  6. Resectability rate in each study arm. [ Time Frame: 4-6 or 10-12 weeks after completed CRT ]
  7. Safety and toxicity (only grade 3-5 toxicity will be reported) ety and toxicity (only grade 3-5 toxicity will be reported) [ Time Frame: 4-6 or 10-12 weeks after completed CRT ]
    According to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

  8. Postoperative complications in each study arm. [ Time Frame: 30 days after surgery ]
    Using the classification in the Swedish National Registry for Gastric and Esopgageal Cancer (NREV), including Clavien-Dindo classification.

  9. Health-related quality of life (HRQOL). [ Time Frame: 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. ]
    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.

  10. QUALYs at 5 year follow-up in each study arm. [ Time Frame: 5 years after surgery ]
    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.

  11. Correlation between symptom scores, endoscopy and radiology; and complete histological response. [ Time Frame: 4 weeks after surgery ]
  12. Nutritional status of patients in each study arm. [ Time Frame: within a week before the start of CRT, within a week before surgery and 5 years after surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically verified adenocarcinoma or SCC of the esophagus or GEJ Siewert type I and II.
  • Tumors should be resectable and without distant metastasis, as assessed after completed CRT.
  • Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
  • Pre CRT tumor stage: T1N1-3M0, T2N0-3M0, T3N0-3,M0, T4aN0-3,M0
  • Written informed consent
  • Completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant CRT schedule according to protocol within a period of <36 days.

Exclusion Criteria:

  • Concomitant malignant diagnosis (excluding non-melanoma skin cancer) <5 years since current cancer diagnosis.
  • Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy.
  • Patients being unable to comply with the protocol for reasons of language or cognitive function.
  • Tumor stage T1N0, T4bNX or TXNXM1.
  • Carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy.
  • Clear radiological signs of tumor progression during CRT on CT-scan after completion of CRT. PET is not used in this decision as FDG-activity often increase due to radiotherapy induced inflammation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415101


Locations
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Sweden
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Oslo University Hospital
Haukeland University Hospital
St. Olavs Hospital
Lund University Hospital
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Region Örebro County
University Hospital, Umeå
Investigators
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Principal Investigator: Magnus Nilsson, Prof Karolinska University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magnus Nilsson, Associate professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02415101    
Other Study ID Numbers: 2014/748-31-3
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by Magnus Nilsson, Karolinska University Hospital:
Adenocarcinoma
Squamous cell carcinoma
Gastroesophageal Junction
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases