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Trial registered on ANZCTR


Trial ID
ACTRN12614000821695
Ethics application status
Approved
Date submitted
23/07/2014
Date registered
1/08/2014
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of hypofractionated radiotherapy with carboplatin and paclitaxel in palliative management of esophageal cancers
Scientific title
Study to assess the safety of hypofractionated radiotherapy with concurrent carboplatin and paclitaxel in palliative management of esophageal cancers.
Secondary ID [1] 285045 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal Cancer 292560 0
palliation of dysphagia 292563 0
Condition category
Condition code
Cancer 292870 292870 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289881 0
Treatment: Other
Intervention code [2] 289918 0
Treatment: Drugs
Comparator / control treatment
Single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292741 0
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.
Timepoint [1] 292741 0
At 6 weeks after completion of intervention.
Secondary outcome [1] 309587 0
Secondary Endpoints:
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.
Timepoint [1] 309587 0
Up to 1 year
Secondary outcome [2] 309680 0
Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the Mellow scale.
Timepoint [2] 309680 0
up to 1 year
Secondary outcome [3] 309681 0
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.
Timepoint [3] 309681 0
up to 1 year
Secondary outcome [4] 309683 0
Changes in patient reported Quality of Life measured using the EORTC QLQ-C15-PAL.
Timepoint [4] 309683 0
up to 1 year
Secondary outcome [5] 309684 0
Overall survival time (median and range)
Timepoint [5] 309684 0
up to 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase 1 design
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2765 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 8463 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 289652 0
Self funded/Unfunded
Name [1] 289652 0
Not applicable
Address [1] 289652 0
Not applicable
Country [1] 289652 0
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Edith Street,
Waratah 2298, NSW
Country
Australia
Secondary sponsor category [1] 288341 0
None
Name [1] 288341 0
Address [1] 288341 0
Country [1] 288341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291388 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291388 0
Research Ethics and Governance Unit
Locked bag 1, New Lambton, NSW, 2305
Ethics committee country [1] 291388 0
Australia
Date submitted for ethics approval [1] 291388 0
Approval date [1] 291388 0
18/07/2014
Ethics approval number [1] 291388 0
14/06/18/3.05

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50170 0
A/Prof Jarad Martin
Address 50170 0
Department of Radiation Oncology,
Calvary Mater Newcastle,
Edith Street, Waratah 2298, NSW
Country 50170 0
Australia
Phone 50170 0
+61 2 4014 3631
Fax 50170 0
Email 50170 0
jarad.martin@calvarymater.org.au
Contact person for public queries
Name 50171 0
Ms Sarah Gallagher
Address 50171 0
Department of Radiation Oncology,
Calvary Mater Newcastle,
Edith Street, Waratah 2298, NSW
Country 50171 0
Australia
Phone 50171 0
+6124014 3949
Fax 50171 0
Email 50171 0
sarah.gallagher@calvarymater.org.au
Contact person for scientific queries
Name 50172 0
A/Prof Jarad Martin
Address 50172 0
Department of Radiation Oncology,
Calvary Mater Newcastle,
Edith Street, Waratah 2298, NSW
Country 50172 0
Australia
Phone 50172 0
+61 2 4014 3631
Fax 50172 0
Email 50172 0
jarad.martin@calvarymater.org.au