Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

NCT01047969 | Unknown Phase 2

• 1 other identifier: 2759
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative CRT study is to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up protocol in a small group of patients where the cancer becomes undetectable by imaging modalities.

Conditions

Rectal Adenocarcinoma

Keywords

locally invasive high-risk rectal adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

  Two years post end of chemoradiotherapy

• 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.

  Two years post end of chemoradiotherapy

Secondary Outcomes (7)

• Time to distant disease

  The time to the first diagnosis of lymph node or other distant disease, confirmed via PET/CT, MRI, CT or pathology

• Time to maximal tumour response after CRT

  The time when tumour regressed to its minimum thickness and when MRI

• Time to local re-growth

  The time until the first recorded increase in Mandard grade, or tumour thickness or length, on MRI

• Percentages of positive margins, and sphincter-preservation rates in patients who have had surgery

  At the end of the study - all patients who had surgery for progression of local disease

• Progression-free and overall survival

  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).

Interventions

Adjuvant Chemotherapy DRUG

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

Surgery PROCEDURE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemotherapy, Adjuvant; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Julie Curtis

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: June 6, 2006
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 13, 2019

Record last verified: 2016-05

Locations

GB (1)