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Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Adenocarcinoma

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Trial Information

Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Safety Issue:

Yes

Authority:

United Kingdom: Research Ethics Committee

Study ID:

2759

NCT ID:

NCT01047969

Start Date:

September 2006

Completion Date:

June 2019

Related Keywords:

  • Rectal Adenocarcinoma
  • locally invasive high-risk rectal adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

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