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Clinical Trials/NCT06521827
NCT06521827
Not Yet Recruiting
N/A

The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum

Assiut University0 sites49 target enrollmentAugust 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metastatic Cancer Rectum
Sponsor
Assiut University
Enrollment
49
Primary Endpoint
The role of short course of palliative radiation in metastatic cancer rectum.
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Detailed Description

All patients will be under go complete history and physical examination, proctoscopy and biopsy, followed by metastatic work up include chest X ray, pelvic abdominal CT. Radiotherapy: Target volume: all the gross primary disease and gross nodal involved plus 2 cm safety margin will be included. not involved node will not be included. Dosage: total dose of 25 Gy over 5 fractions through 1 weak will be given. Time: Radiotherapy will be given first and chemotherapy will be given after 1 weak rest to avoid the over lapping toxicity. Chemo therapy: To be started after 1 weak rest after radiotherapy. CAPOX (oxaliplatin given intravenously at 130 mg/m2 on day 1, followed by oral capecitabine 1000 mg/m2 twice daily on days 1-14, in a 3-week cycle). or folfox (leucovorin calcium (IV 200 mg/m2 on day 1,2,15,16 ) + 5 fluorouracil (IV 600 mg/m2 on day 1,2,15,16)+ oxaliplatin (IV 85 mg/m2 on day 1, 15) plus target agent according to RAS status if wild for bevacizumab ( IV 5 ml/kg on day 1, 15) or cetiximab (IV 250 mg/m2 on day 1,8,15, 22) or vectibex (IV 6mg/kg on day 1,15) Surgery: Surgery if complete bowel obstruction as palliation or as treatment if controlled metastatic sites and primary Follow up: CT pelvi-abdomen will be done after 3 cycle of chemotherapy to assess the response then after end of CTH every 3 month in first year. Toxicity of RTH will be collected before and after RTH.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ehdaa Khaled Mahmoud

resident doctor at radiotherapy department at south Egypt cancer institute

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: one year

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

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