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

Assiut University

Status: Not yet enrolling

Conditions: Metastatic Cancer Rectum

Treatments: Radiation: short course radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06521827

SCRTH in rectal cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

short course radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: short course radiotherapy