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Short-course radiotherapy with delayed surgery in unfit locally advanced rectal cancer patients.

Short-course radiotherapy with delayed surgery in unfit locally advanced rectal cancer patients.

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Observational
Source
TCTR
Registry ID
TCTR20150617001
Enrollment
Unknown
Registered
2015-06-17
Start date
2007-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

locally advanced rectal cancer rectal cancer&#44

Interventions

Patients with locally advanced rectal cancer (LARC) unfit for chemotherapy were enrolled. The reasons for given short course radiotherapy (SCRT) were co&#45
morbidities and/or age ≥ 75 years.
Treatment
SCRT patients

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
51 Years to 93 Years

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&#44; as measured by rigid sigmoidoscopy); no evidence of distant metastases on a chest and abdomen CT scan; active co&#45;morbidities (defined by the co&#45;morbidity index according to the Charlson score) (23) which made patients unfit for chemotherapy; logistical difficulties in receiving standard treatment with or without co&#45;morbidities; patient refusal of chemotherapy.

Exclusion criteria

Exclusion criteria: ineligibility for surgery&#44; previous pelvic RT or active pelvic inflammatory disease.

Design outcomes

Primary

MeasureTime frame
feasibility at the end of every patient follow&#45;up (median follow&#45;up 30 months) EORTC&#45;RTOG scale

Secondary

MeasureTime frame
The 3&#45;year probability of Local Recurrence Free Survival (LRFS) local relapse onset (median follow&#45;up 30 months) time from treatment beginning to relapse,Distant Metastasis Free Survival (DMFS)&#44; Cancer Specific Survival (CSS) metastases onset or death from cancer specific cause (median follow&#45;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

Public ContactMarco Lupattelli

Ospedale S.M.Della Misercordia Perugia

kiralupis@libero.it0755783614

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026