Therapy of locally advanced rectal cancer of the upper third by quality controlled total versus partial mesorectal excision

Therapy of cUICC stage II/III rectal cancer of the upper third by quality controlled total versus partial mesorectal excision, followed by adjuvant chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35198481

Enrollment

360

Registered

2008-02-13

Start date

2007-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer Cancer Rectal cancer

Interventions

For all procedures, standard operating procedures (SOPs) are available. Experimental intervention: 1. Arm A: total mesorectal excision (TME) including surgical and pathological quality control, fol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed advanced primary rectum carcinoma at a level 12 - 16 cm above the anocutaneous verge (as measured by rigid endoscopy), endosonographically classified as uT3-4 or uN+ carcinomas, no evidence for synchronous distant metastases 2. Patients aged 18 - 85 years, either sex 3. No preliminary treatment of rectum carcinoma

Exclusion criteria

Exclusion criteria: 1. Successfully treated secondary malignoma with the exception of basal cell carcinoma of the skin and in situ cervix carcinoma, respectively, The inclusion of patients with other tumours, that have been treated successfully and have not reappeared during the last 5 years, has to be discussed with the principal investigator 2. Simultaneous therapy with other anti-cancer drugs 3. Chronic colonic diseases

Design outcomes

Primary

Measure	Time frame
Disease-free survival after 3 years (local and/ or distant recurrences).	—

Secondary

Measure	Time frame
1. R0-rate of resection 2. Post-operative 30-day lethality 3. Post-operative morbidity (especially rate of anastomotic insufficiencies) 4. Cumulative incidence of local relapses and distant metastases 5. Survival after 3 and 5 years 6. Acute and late toxicity of the chemotherapy according to the Common Toxicity Criteria of the National Cancer Institute (NCI CTC version 2.0) 7. Post-operative late complications (defaecation problems, anastomotic stenoses, loss of sphincter function) 8. Quality of TME and PME as assessed 9. Quality of life according to the European Organisation for Research and Treatment of Cancer (EORTC)-Questionnaire QLQ-30 (3.0) Assessment of safety: TME, PME, and adjuvant chemotherapy are established procedures.	—

Measure

Time frame

1. R0-rate of resection 2. Post-operative 30-day lethality 3. Post-operative morbidity (especially rate of anastomotic insufficiencies) 4. Cumulative incidence of local relapses and distant metastases 5. Survival after 3 and 5 years 6. Acute and late toxicity of the chemotherapy according to the Common Toxicity Criteria of the National Cancer Institute (NCI CTC version 2.0) 7. Post-operative late complications (defaecation problems, anastomotic stenoses, loss of sphincter function) 8. Quality of TME and PME as assessed 9. Quality of life according to the European Organisation for Research and Treatment of Cancer (EORTC)-Questionnaire QLQ-30 (3.0) Assessment of safety: TME, PME, and adjuvant chemotherapy are established procedures.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026