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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06521827
Enrollment
49
Registered
2024-07-26
Start date
2024-08-31
Completion date
2026-12-31
Last updated
2024-07-26

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

Conditions

Metastatic Cancer Rectum

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.

Interventions

short course palliative radiotherapy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Adenocarcinoma pathological evidence in rectal carcinoma. 2. Metastatic unresectable rectal cancer. 3. Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,

Exclusion criteria

1. Previous radiotherapy. 2. Concomitant chemotherapy. 3. Previously created stoma.

Design outcomes

Primary

MeasureTime frameDescription
The role of short course of palliative radiation in metastatic cancer rectum.one yearThe role of short course of palliative radiation in metastatic cancer rectum.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026