Clinical trial · Interventional

Palliative Short-Course Radiotherapy in Rectal Cancer

Palliative Short-Course Radiotherapy in Rectal Cancer: A Phase II Study

NCT02639403CI-TRIAL-00020325completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have been published more than two decades ago and were based on 2D conventional RT, which is nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the management of symptomatic rectal cancer are still lacking. The aim of this prospective study was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with symptomatic obstructive rectal cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rectal Neoplasms	Rectal Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Conformal three-dimensional Radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
RT for Obstructing Rectal Cancer
description
Conformal three-dimensional RT was planned (3D-RT) in patients with obstructing rectal cancer not amenable for curative resection
interventionNames
1. Radiation: Conformal three-dimensional Radiotherapy

Primary outcomes (1)

measure
Change of the obstructive symptoms
timeFrame
Clinical evaluation was performed before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

Secondary outcomes (5)

measure
Change of the overall symptoms
timeFrame
Before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* (i) rectal adenocarcinoma with obstructive symptoms not amenable for curative treatment due to synchronous metastases or patient inoperable due to age and/or comorbidities;
* (ii) symptoms of colorectal obstruction (progressive constipation with abdominal pain arising from less than 2 months, vomiting and/or diarrhea) and/or signs of obstruction at radiological examinations (presence of air-fluid levels or the presence of distended colon upstream neoplastic stenosis of the rectum);
* (iii) candidates for derivative colostomy;
* (iv) bi-dimensionally measurable disease;
* (v) Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* (vi) able to provide a written informed consent.

Exclusion Criteria:

* (i) RT within 6 months in the same anatomical area before the initiation of study treatment;
* (ii) clinically detectable ascites;
* (iii) pregnancy

References

Publications (0)

Data not yet available

No reference posted for this study.