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NCT Number: NCT02415101

Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer

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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Key information

Conditions

Cancer of the Esophagus Adenocarcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

Stockholm, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resective surgery

Procedure

Primary outcomes

  1. Complete histological response proportion, using the Chirieac grading system.

    Time frame: analysis is completed 4 weeks after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Lund University Hospital
  • Oslo University Hospital
  • Region Örebro County
  • Sahlgrenska University Hospital
  • St. Olavs Hospital
  • University Hospital Cologne
  • University Hospital of North Norway
  • University Hospital, Linkoeping
  • University Hospital, Umeå

Registry information

Official study title

Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia

Acronym: NeoResII

Important dates

Study start
2015
Primary completion
2019
Study completion
2024
First posted
Apr 14, 2015
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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