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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12606000526572
Date of registration:	22/12/2003
Prospective Registration:	No
Primary sponsor:	Trans Tasman Radiation Oncology Group
Public title:	Advanced oesophageal cancer study to compare quality of life and palliation of dysphagia
Scientific title:	Trans Tasman Radiation Oncology Group (TROG) 03.01 - A randomised phase III study in advanced oesophageal cancer to compare quality of life and palliation of dysphagia in patients treated with radiotherapy versus chemo-radiotherapy (cisplatin & 5-Flurouracil).
Date of first enrolment:	07/07/2003
Target sample size:	220
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12606000526572.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
Phase:	Phase 3

Countries of recruitment
Australia	Canada	New Zealand	United Kingdom

Contacts

Name:	Ms Sonya Stephens
Address:	Royal Adelaide Hospital Radiation Oncology North Terrace Adelaide SA 5000 Australia
Telephone:	+61 8 8222 4042
Email:	sonya.stephens@health.sa.gov.au
Affiliation:

Name:	Dr Michael Penniment
Address:	Royal Adelaide Hospital Radiation Oncology North Terrace ADELAIDE SA 5000 Australia
Telephone:	+61 8 8222 4000
Email:	mpennime@mail.rah.sa.gov.au
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Biopsy proven carcinoma of the Oesophagus
2. 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).
3. Symptomatic patients with dysphagia scores of => 1 i.e. able to eat only some sollids (see appendix 1)
4. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
5. Patients msut begin treatment within 2 weeks of randomisation
6. Patient is at least 18 years old
7. Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L
8. Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1).
9. Patients capable of child bearing are using adequate contraception.
10. Written informed consent of patient.
Exclusion criteria: 1. Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients.
4. Patients unfit for any treatment component.
5. Tracheo-oesophageal fistula.
6. Stents in situ.
7. Previous chemotherapy for Oesophageal Cancer
8. CT scan of thorax and abdomen more than 8 weeks prior to randomisation
9. Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Oesophageal (gullet)

Advanced oesophagus cancer, not suitable for radical treatment.;
Advanced oesophagus cancer, not suitable for radical treatment.

Intervention(s)

Arm 2: Chemo-radiotherapy. 35Gy in 15 fractions (Overall, treatment time will not exceed 25 days total for the 3 week course and 18 days for the 2 week course of radiation) plus Cisplatin 80mg/m squared IV day 1 (or 20mg/m sqaured/day IV each day from 1-4 only one cycle) plus 5-Fluorouacil 800mg/m squared/day IV days 1-4 (radiotherapy and chemotherapy are simultaneous)

Primary Outcome(s)

Relief of dysphagia. Defined as improvment of at least one point on the Mellow scale. [This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.]

Secondary Outcome(s)

1. Dysphagia progression free survival.[Measured from randomisation to the time of first progression of dysphagia. Progression will be defined as a drop of at least one point on the scale or stricture requiring intervention or death. Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients). ]

2. Time to achieve any response in dysphagia.[Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients).]

3. Quality of Life[Differences post treatment (at the end of the treatment cycles) and at monthly intervals for the first 12 months and then 3 monthly until death (all patients). ]

4. Acute and late toxicity. [ Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients).]

5. Survival.[All patients followed until death.]

Secondary ID(s)

clinicalTrials.gov ID NCT00193882

Source(s) of Monetary Support

Cancer Council Tasmania

National Cancer Institute of Canada

National Health & Medical Research Council

Secondary Sponsor(s)

National Cancer Institute of Canada (NCIC)

Ethics review

Status: Approved
Approval date:
Contact:

AHSC St John Regional Health