Surgery alone In low rectal cancer

Not Applicable

• Conditions: Rectal cancer; Cancer

• Registration Number: ISRCTN02406823
• Lead Sponsor: Morriston Hospital (UK)

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27872117

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-06
• Last Update Posted: 5 May 2019
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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 the disease-free interval is = 5 years)
22. No prior pelvic radiation

Previous inclusion criteria:
1. Aged 18 years and older
2. Pathologically 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 excision (APER)
5. Potentially resectable local disease by surgery alone with clear margins as determined by MRI
6. Clinical disease stage (MRI+/- endorectal US):
6.1. T3a/b/c disease
6.2. T4 disease with sole involvement of internal/external sphincter/ adjacent (<10mm) levator plate or posterior wall of vagina
6.3. TanyN1 (resectable)
7. WHO Performance status 0, 1, or 2
8. Neutrophil count = 1,500/mm³
9. Platelets = 100,000/mm³
10. Haemoglobin > 8.0 g/dL
11. Total bilirubin = 1.5x ULN
12. AST & ALT = 3 x ULN
13. Creatinine = 1.5 x ULN
14. Negative pregnancy test
15. Patient of child-bearing potential willing to employ adequate contraception
16. Willing to return to enrolling medical site for all study assessments
17. No other invasive maligna

Exclusion Criteria

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 involvement
3. Early stage rectal cancer (T1, T2) unless node positive
4. Locally perforated disease (T4a)
5. Disease extrusion through anus
6. Lateral pelvic/ paraaortic lymphadenopathy
7. Metastatic disease (M1)
8. Previous pelvic radiotherapy
9. Pregnancy
10. Contraindication to 5-FU based chemotherapy
11. WHO Performance Status 3 or 4
12. Unwilling to consent to trial participation

Criteria for Premature Withdrawal
1. Withdrawal of consent
2. Failure to meet inclusion criteria (delayed)
3. Development of irresectable metastatic disease
4. Development of irresectable primary tumour after randomisation
5. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified