Last updated on July 2019

"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rectal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
  • Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
  • Patients aged 18 years of age are eligible for inclusion. However, patients aged 40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W&W approach after careful consideration and well-documented informed consent are eligible for entering the W&W protocol.
  • Given informed consent
  • Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included

Exclusion Criteria:

  • Patients without cCR
  • Patients unable to give informed consent
  • Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
  • Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
  • Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
  • Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy
  • Other circumstances that may interfere with successful participation in the W&W protocol

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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