Clinical trial · Interventional
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.
- 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)
To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.
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 |
|---|---|---|---|
| Esophagus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Radiotherapy
- description
- Radiotherapy alone
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- B: Chemo-radiotherapy
- description
- Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
- interventionNames
- Drug: Cisplatin
- Radiation: Radiotherapy
- Drug: 5-Fluorouracil
Primary outcomes (1)
- measure
- Relief of dysphagia
- timeFrame
- This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven Carcinoma of the oesophagus. * Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment). * Symptomatic patients with dysphagia scores of ≥ 1 i.e. able to eat only some solids (see Mellow Scale appendix 1) * Performance status ECOG ≤ 2 * Patients must begin treatment within 2 weeks of randomization. * Patient is at least 18 years old. * Adequate haematological function to undergo chemotherapy. Peripheral blood - Neutrophils \> 1.5 x 10\^9/L - Platelets \> 100 x 10\^9/L * Adequate renal function, Creatinine - Calculated clearance ≥ 50 ml/min * Patients capable of childbearing are using adequate contraception. * Written informed consent of patient. Exclusion Criteria: * Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest. * Synchronous active malignancies. * Pregnant or lactating patients. * Patients unfit for any treatment component. * Tracheo-oesophageal fistula. * Stents in situ. * Previous chemotherapy for Oesophageal Cancer * CT scan of thorax and abdomen more than 8 weeks prior to randomization * Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization
References
Publications (1)
- DERIVEDPenniment MG, De Ieso PB, Harvey JA, Stephens S, Au HJ, O'Callaghan CJ, Kneebone A, Ngan SY, Ward IG, Roy R, Smith JG, Nijjar T, Biagi JJ, Mulroy LA, Wong R; TROG 03.01/CCTG ES.2 group. Palliative chemoradiotherapy versus radiotherapy alone for dysphagia in advanced oesophageal cancer: a multicentre randomised controlled trial (TROG 03.01). Lancet Gastroenterol Hepatol. 2018 Feb;3(2):114-124. doi: 10.1016/S2468-1253(17)30363-1. Epub 2017 Dec 14. PMID 29248399