NCT06521827

Brief Summary

Short-course radiotherapy (SCRT), which allows the delivery of 25 Gy in five daily fractions, has emerged as an attractive strategy for rectal cancer treatment. Surgery can safely be deferred after SCRT, allowing an opportunity to deliver chemotherapy (ChT) preoperatively rather than postoperatively. In cases of metastatic disease, this represents an effective treatment option to improve local control and avoid colostomy in a subset of patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Aug 2024

Typical duration for not_applicable

Status
not yet 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 Progress76%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

July 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

July 17, 2024

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The role of short course of palliative radiation in metastatic cancer rectum.

    The role of short course of palliative radiation in metastatic cancer rectum.

    one year

Study Arms (1)

short course radiotherapy

EXPERIMENTAL

patients with metastatic rectal cancer will receive short course of radiotherapy befor staring chemotherapy

Radiation: short course radiotherapy

Interventions

short course palliative radiotherapy

short course radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adenocarcinoma pathological evidence in rectal carcinoma.
  • Metastatic unresectable rectal cancer.
  • Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,

You may not qualify if:

  • Previous radiotherapy.
  • Concomitant chemotherapy.
  • Previously created stoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Santucci C, Mignozzi S, Malvezzi M, Boffetta P, Collatuzzo G, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2024 with focus on colorectal cancer. Ann Oncol. 2024 Mar;35(3):308-316. doi: 10.1016/j.annonc.2023.12.003. Epub 2024 Jan 28.

    PMID: 38286716BACKGROUND
  • Flyum IR, Mahic S, Grov EK, Joranger P. Health-related quality of life in patients with colorectal cancer in the palliative phase: a systematic review and meta-analysis. BMC Palliat Care. 2021 Sep 16;20(1):144. doi: 10.1186/s12904-021-00837-9.

    PMID: 34530833BACKGROUND
  • Yoo RN, Cho HM, Kye BH. Management of obstructive colon cancer: Current status, obstacles, and future directions. World J Gastrointest Oncol. 2021 Dec 15;13(12):1850-1862. doi: 10.4251/wjgo.v13.i12.1850.

    PMID: 35070029BACKGROUND
  • van Hooft JE, Veld JV, Arnold D, Beets-Tan RGH, Everett S, Gotz M, van Halsema EE, Hill J, Manes G, Meisner S, Rodrigues-Pinto E, Sabbagh C, Vandervoort J, Tanis PJ, Vanbiervliet G, Arezzo A. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 May;52(5):389-407. doi: 10.1055/a-1140-3017. Epub 2020 Apr 7.

    PMID: 32259849BACKGROUND
  • Tissera NS, Freile B, Waisberg F, Esteso F, Galli M, Loria FS, Luca R, Pedraza II, Enrico DH, Chacon C, Huertas E, Chacon MR, O'Connor JM. Short-course radiotherapy for rectal cancer: real-world evidence in Argentina. Ecancermedicalscience. 2023 Jun 1;17:1555. doi: 10.3332/ecancer.2023.1555. eCollection 2023.

    PMID: 37396101BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at radiotherapy department at south Egypt cancer institute

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 26, 2024

Study Start

August 1, 2024

Primary Completion

August 1, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

July 26, 2024

Record last verified: 2024-07