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

Study to assess the safety of hypofractionated radiotherapy with concurrent carboplatin and paclitaxel in palliative management of esophageal cancers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000821695

Acronym

Nil

Enrollment

Registered

2014-08-01

Start date

2014-10-09

Completion date

2019-03-25

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess the safety of using hypofractionated radiotherapy concurrent with carboplatin and paclitaxel chemotherapy regimen for the palliative management of esophageal cancers. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with esophageal cancer for which curative surgery or radical chemoradiotherapy is not appropriate, and are experiencing symptoms of dysphagia (difficulty swallowing). Study details The first three participants in this study will undergo a total of 15 sessions of hypofractionated radiotherapy together with weekly intravenous injections (into the veins) of the chemotherapy drugs Carboplatin and Paclitaxel. If the initial regimen is tolerated in the participants, the radiotherapy dose given per session will be increased in subsequent groups (resulting in smaller total number of sessions). Participants will be monitored for safety throughout the treatment. They will also be followed for up to 1 year in order to evaluate treatment effect on dysphagia,quality of life and survival time.

Interventions

Hypofractionated radiotherapy with concurrent carboplatin and paclitaxel chemotherapy. Patients will be enrolled onto one of four radiotherapy schedules,with increasing dose given per fraction with each subsequent schedule. Schedule one starts at 35Gy in 15 fractions (2.33Gy per fraction) given over 3 weeks. Schedule two is 35Gy in 14 fractions (2.5Gy per fraction) given over 2.8 weeks. Schedule three is 33Gy in 12 fractions (2.75Gy per fraction) given over 2.4 weeks. Schedule four is 30Gy in 10 fractions (3.0Gy per fraction) given over 2 weeks. Weekly intravenous Carboplatin (AUC 2) and Paclitaxel (50mg per square meter of body surface area) will be given concurrently with the radiotherapy, such that depending on the radiotherapy schedule, the participants may receive either 2 or 3 cycles.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results