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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Rectal cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27872117 protocol
You can take part if:
Current inclusion criteria as of 24/02/2014:
1. Age 18 years and older
2. Histologically confirmed rectal adenocarcinoma
3. Radiologically measurable or clinically evaluable disease
4. Low rectal cancer, defined as within 6cm of anal verge on rigid sigmoidoscopy and considered to require abdominoperineal resection (APR) rather than restorative procedure (anterior resection)
5. Potentially resectable local disease by surgery alone with clear CRM (where visible on MRI) or predicted surgical resection margin (where CRM absent in distal tumours) as determined by MRI
6. Clinical disease stage (MRI+/- endorectal US):
6.1. cT3a/b (<10 mm) disease within 6 cm of anal verge; or for tumours at/below level of puborectalis
6.2. through full thickness of muscularis propria (cT2) disease at level of puborectalis
7. Involvement of internal anal sphincter or intersphincteric space without extension into adjacent levator plate,
8. TanyN1 (resectable)
9. WHO Performance status 0, 1, or 2
10. Neutrophil count ≥ 1,500/mm³
11. Platelets ≥ 100,000/mm³
12. Haemoglobin > 80 g/L
13. Total bilirubin ≤ 1.5x ULN
14. AST & ALT ≤ 3 x ULN
15. Creatinine ≤ 1.5 x ULN
16. Negative pregnancy test
17. Patient of child-bearing potential willing to employ adequate contraception
18. Willing to return to enrolling medical site for all study assessments
19. No other invasive malignancy ≤ 5 years prior to registration
20. No concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study
21. No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if th
You may not be able to take part if:
Current exclusion criteria as of 24/02/2014:1. Preoperative chemoradiotherapy absolutely indicated, for example MRI-predicted CRM/MRF involvement (<1 mm) by primary or nodal disease, or otherwise unresectable disease;2. cT3c or d (>10 mm);3. Adjacent organ involvement at entry (prostate, seminal vesicles, sacrum or coccyx; T4b) requiring multivisceral resection/ pelvic exenteration;4. For low tumours at level of puborectalis sling: lateral extension of tumour into external anal sphincter or beyond puborectalis sling into levator plate;5. Extramural vascular invasion on MRI;6. Early stage rectal cancer (T1, T2 above level of levators) unless node positive;7. Locally perforated disease (T4a);8. Fistulating disease (vagina, perianal skin, adjacent hollow organ);9. Disease extrusion through anus;10. cN2 disease;11. Lateral pelvic/ para-aortic lymphadenopathy (>10 mm by size criteria);12. Unresectable metastatic disease (M1) (potentially resectable disease permitted);13. Previous pelvic radiotherapy;14. Unfit for major surgery;15. Pregnancy;16. Contraindication to MRI (metal implants etc);17. Contraindication to 5-FU based chemotherapy (including drug interactions);18. WHO Performance Status 3 or 4;19. Unwilling to consent to trial participation
Previous exclusion criteria:1. Preoperative chemoradiotherapy absolutely indicated, for example predicted CRM involvement (<2 mm) by primary or nodal disease, or otherwise unresectable disease;2. Adjacent organ involvement (prostate, seminal vesicles, sacrum or coccyx; T4b) requiring multivisceral resection/pelvic exenteration; wide (>10mm) levator involvement3. Early stage rectal cancer (T1, T2) unless node positive4. Locally perforated disease (T4a)5. Disease extrusion through anus6. Lateral pelvic/ paraaortic lymphadenopathy7. Metastatic disease (M1)8. Previous pelvic radiotherapy9. Pregnancy10. Contraindication to 5-FU based chemotherapy11. WHO Performance Status 3 or 412. Unwilling to consent to trial participation
Criteria for Premature Withdrawal1. Withdrawal of consent2. Failure to meet inclusion criteria (delayed)3. Development of irresectable metastatic disease4. Development of irresectable primary tumour after randomisation5. Change in surgical procedure following chemoradiotherapy. In the event of significant tumour regression a sphincter-saving operation (low anterior resection) may be considered more appropriate by the responsible clinician than a sphincter-excising APR procedure.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Prof
Dean
Harris
+44 (0)1792 285 459
Dean.Harris2@wales.nhs.uk
The study is sponsored by Morriston Hospital (UK) and funded by Funding decision awaited from Cancer Research UK (July 2014).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 20482
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