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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NCT07258797

Adenocarcinoma of the Rectum

NOT_YET_RECRUITING NA

Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

NCT02510378

Stage IV Rectal Cancer, Liver Metastasis, Resectable

UNKNOWN PHASE2

Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer

NCT04139967

Cancer, Rectal

TERMINATED NA

Palliative Short-Course Radiotherapy in Rectal Cancer

NCT02639403

Rectal Neoplasms

COMPLETED PHASE2

Oligometastases of the LIVer Treated With Chemotherapy With ou Without Extracranial Stereotactic Body Radiation Therapy in Patients With Colorectal Cancer

NCT03532204

Liver Metastases Colorectal Cancer

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Cancer Rectum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

short course radiotherapy

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

Group Type EXPERIMENTAL

short course radiotherapy

Intervention Type RADIATION

short course palliative radiotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

short course radiotherapy

short course palliative radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,