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Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ann Gandolfi, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01047969
First received: January 12, 2010
Last updated: May 27, 2016
Last verified: May 2016
  Purpose
An assessment of the safety of omission of surgery following a complete response to chemotherapy and radiotherapy, or radiotherapy alone, for rectal cancer.

Condition Intervention Phase
Rectal Adenocarcinoma
Drug: Adjuvant Chemotherapy
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To estimate the percentage of patients who can safely omit surgery, defined as the percentage of patients at two years after end of CRT who have not had surgery and who are in CR (no detectable local disease) [ Time Frame: Two years post end of chemoradiotherapy ] [ Designated as safety issue: Yes ]
  • To prove the safety of deferred surgery, as measured by the percentage of patients who have local failure at two years, where local failure is defined as positive margin status of resected tumour or surgically unsalvageable disease. [ Time Frame: Two years post end of chemoradiotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to distant disease [ Time Frame: The time to the first diagnosis of lymph node or other distant disease, confirmed via PET/CT, MRI, CT or pathology ] [ Designated as safety issue: Yes ]
  • Time to maximal tumour response after CRT [ Time Frame: The time when tumour regressed to its minimum thickness and when MRI ] [ Designated as safety issue: No ]
  • Time to local re-growth [ Time Frame: The time until the first recorded increase in Mandard grade, or tumour thickness or length, on MRI ] [ Designated as safety issue: No ]
  • Percentages of positive margins, and sphincter-preservation rates in patients who have had surgery [ Time Frame: At the end of the study - all patients who had surgery for progression of local disease ] [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Time Frame: Measured from the end of CRT (cohort A) or end of adjuvant chemotherapy (cohort B). Surviving patients in continued CR will be censored at the date of last follow-up (clinic visit or imaging). ] [ Designated as safety issue: No ]
  • Quality of Life including long-term bowel, urinary and sexual function [ Time Frame: 10 years after registration, or five years post-surgery. ] [ Designated as safety issue: No ]
  • To correlate the expression of biological markers which may predict for pathological complete response with progression free survival [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: September 2006
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adjuvant Chemotherapy
    If after MRI + FDG-PET 8 weeks post CRT the patient shows no visible tumour or further regression adjuvant chemotherapy will be considered.
    Procedure: Surgery
    If after MRI + FDG-PET 8 weeks post CRF no further regression or growth of disease occurs the patient will be referred for surgery.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Locally invasive high-risk rectal adenocarcinoma as defined by the presence on MRI of at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved ii)T3 tumours at/below levators iii)Tumours extending ≥5mm into peri-rectal fat iv)T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins) v)Presence of extra-mural venous invasion (primary tumour is therefore at least T3) vi)T2 N0/1/2 tumours requiring Abdomino-Perineal Excision, within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved
  • The absence of malignant pelvic side-wall disease, local recurrence (either after TME or wide local excision) or metastatic disease
  • Completion of pre-operative long-course CRT
  • No viable disease seen at MRI performed 4 weeks after long-course CRT, confirmed at 8 week MRI
  • Evidence of partial response of rectal tumour to pre-operative long-course CRT at 4 week MRI which continues to show an incremental response at 8 week MRI.
  • Histological diagnosis of adenocarcinoma of rectum.
  • WHO performance status 0, 1 or 2.
  • No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
  • Informed written consent

Exclusion Criteria:

  • Age < 18 years.
  • Absence of concomitant chemotherapy.
  • RT dose below 50Gy.
  • Stable disease at 4 week MRI.
  • Disease that demonstrates a partial response at 4 week MRI but shows no evidence of an incremental response at 8 week MRI.
  • Pregnancy or breast feeding
  • Short course pre-operative radiotherapy
  • Previous pelvic radiotherapy
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Any contra-indication to MRI scanning, eg Cardiac Pacemaker or Hip prosthesis.
  • Any patients within the EXPERT-C trial.
  • Tumours which are mucinous (>50% mucin seen on MRI), as these are more likely to be PET negative
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047969

Locations
United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Ann Gandolfi, Julie Curtis, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01047969     History of Changes
Other Study ID Numbers: 2759 
Study First Received: January 12, 2010
Last Updated: May 27, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
locally invasive high-risk rectal adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 29, 2016