Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

This study is currently recruiting participants.

Verified January 2010 by Royal Marsden NHS Foundation Trust

Sponsor:

Information provided by:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01047969

First received: January 12, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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) [ 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to distant disease
Time to maximal tumour response after CRT
Time to local re-growth
Percentages of positive margins, and sphincter-preservation rates in patients who have had surgery
Progression-free and overall survival
Quality of Life including long-term bowel, urinary and sexual function
To correlate the expression of biological markers which may predict for pathological complete response with progression free survival

Estimated Enrollment:	45
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:

If after MRI + FDG-PET 8 weeks post CRT the patient shows no visible tumour or further regression adjuvant chemotherapy will be considered.

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
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

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

Locations

United Kingdom
Royal Marsden NHS Foundation Trust	Recruiting
London, United Kingdom
Contact: Diana Tait diana.tait@rmh.nhs.uk
Contact: Irene Chong irene.chong@rmh.nhs.uk
Principal Investigator: Diana Tait

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust

More Information

No publications provided

Responsible Party:	Jane Lawrence, 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:	January 12, 2010
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
Adenocarcinoma, Mucinous
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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