Clinical trial · Interventional
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
NCT01157806CI-TRIAL-00004423unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| short course of palliative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiochemotherapy instead of surgery
- interventionNames
- Radiation: short course of palliative radiotherapy
Primary outcomes (1)
- measure
- percentage of patients not requiring palliative surgery during the follow-up
- timeFrame
- every three months
Secondary outcomes (4)
- measure
- The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
- timeFrame
- 3 months
- description
- Assess prospectively by filling forms.
- measure
- Palliative effect of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) * Occurrence of subjective clinical symptoms of the primary tumor * Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings. Exclusion Criteria: * Obstruction of the gastrointestinal tract * Previously constructed stoma * prior radiotherapy of the pelvis
References
Publications (1)
- DERIVEDTyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6. PMID 24013512