Study of hypofractionated radiotherapy with carboplatin and paclitaxel in palliative management of esophageal cancers

Phase 1

Completed

• Conditions: Oesophageal Cancer; palliation of dysphagia; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12614000821695
• Lead Sponsor: Calvary Mater Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-01
• Study Completion: 2020-04-02
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
2.Symptomatic with Mellow dysphagia score of at least 1.
3.Patients not considered amenable to curative surgery or radical chemoradiotherapy due to either patient-related factors or advanced esophageal cancer stage (locoregional lymphadenopathy and/or low volume metastatic disease).
4. ECOG performance status 0-2.
5. No contraindication to receiving weekly carboplatin or paclitaxel chemotherapy including adequate bone marrow function.
6. Above 18 years old.

Exclusion Criteria

1.Previous thoracic radiotherapy.
2.Tracheo-esophageal fistula.
3.Esophageal stents in situ.
4.Previous chemotherapy for esophageal cancer.
5.Presence of bulky or organ-threatening metastatic disease requiring immediate higher dose chemotherapy.
6.Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the incidence of dose limiting toxicities (DLT), as if this is greater than one third of patients in any schedule, the study will close and the previous schedule will be deemed the maximum tolerated.[At 6 weeks after completion of intervention.]

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints:<br>To measure the treatment effect on relief of dysphagia using the 5-point Mellow Scale, defined as improvement of at least one point on the Mellow scale. <br>[Up to 1 year];Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the Mellow scale.[up to 1 year];Dysphagia progression-free survival, measured from enrolment to time of first progression of dysphagia. Progression of dysphagia will be defined as any of the following: a drop of at least 1 point on the dysphagia scale;stricture requiring intervention or death.[up to 1 year];Changes in patient reported Quality of Life measured using the EORTC QLQ-C15-PAL.[up to 1 year];Overall survival time (median and range) [up to 1 year]