locally advanced rectal cancer rectal cancer,
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age over 75 years; histologically confirmed adenocarcinoma of the extraperitoneal rectum (defined as < 12 cm from distal tumour to anal verge, as measured by rigid sigmoidoscopy); no evidence of distant metastases on a chest and abdomen CT scan; active co-morbidities (defined by the co-morbidity index according to the Charlson score) (23) which made patients unfit for chemotherapy; logistical difficulties in receiving standard treatment with or without co-morbidities; patient refusal of chemotherapy.
Exclusion criteria
Exclusion criteria: ineligibility for surgery, previous pelvic RT or active pelvic inflammatory disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility at the end of every patient follow-up (median follow-up 30 months) EORTC-RTOG scale | — |
Secondary
| Measure | Time frame |
|---|---|
| The 3-year probability of Local Recurrence Free Survival (LRFS) local relapse onset (median follow-up 30 months) time from treatment beginning to relapse,Distant Metastasis Free Survival (DMFS), Cancer Specific Survival (CSS) metastases onset or death from cancer specific cause (median follow-up 30 months) time from reatment beginning to metastases onset and death for cancer.,response rate after every patient surgery pTNM classification and tumor regression grade (TRG) criteria as proposed by Mandard | — |
Countries
Italy
Contacts
Ospedale S.M.Della Misercordia Perugia