NCT03853733

Brief Summary

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2016Mar 2027

Study Start

First participant enrolled

October 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10.4 years

First QC Date

February 18, 2019

Last Update Submit

March 18, 2026

Conditions

Rectal Cancer

Keywords

palliative radiotherapyrectal bleedinghypofractionated radiotherapy

Outcome Measures

Primary Outcomes (4)

  • Symptomatic response after palliative radiotherapy (bleeding)

    number of patients with bleeding ( worst, no change, better or without)

    two months afer the end of radiotherapy

  • Symptomatic response after palliative radiotherapy (pain)

    number of patients with pain ( worst, no change, better or without)

    two months afer the end of radiotherapy

  • Gastrointestinal toxicity after the end of radiotherapy

    Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale

    two months afer the end of radiotherapy

  • Genitourinary toxicity after the end of radiotherapy

    Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.

    two months afer the end of radiotherapy

Secondary Outcomes (1)

  • palliative colostomy after the end of palliative radiotherapy

    two months afer the end of radiotherapy

Interventions

rectal cancer radiotherapyRADIATION

Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis.

You may qualify if:

  • Patients with rectal or sigmoidal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis
  • Patients with = or \> 18 years old
  • Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy

You may not qualify if:

  • Patients with a non rectum or sigma colo-rectal cancer.
  • Patients with \<18 years old.
  • Patients treated with concurrent chemotherapy
  • Patients candidates for surgical resection after radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Catalonia, 08227, Spain

RECRUITING

Related Publications (1)

  • EP-1648: Palliative hipofractionated radiotherapy in non operable rectal cancer: preliminary results RSS Download PDF J. Lozano Galan, E. Rubio and J. Solé Radiotherapy and Oncology, 2018-04-01, Volume 127, Pages S887-S887

    BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joan Lozano, MD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Lozano, MD

CONTACT

+34 937003690jlozano@cst.cat

Joan Lozano, MD

CONTACT

+34 937003690jlozano@comb.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 26, 2019

Study Start

October 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)