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Esophagus CancerPhase 3NCT00193882

Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.

A Phase 3 study testing Cisplatin, Radiotherapy and 5-Fluorouracil in people with Esophagus Cancer, run by Trans Tasman Radiation Oncology Group at 25 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagus Cancer
What is being tested?
Cisplatin, Radiotherapy and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
25 sitesin 4 countries
Study dates
7 Jul 2003to 18 Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

Australia15 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Premion - Wesley

    Auchenflower, Queensland, 4006

  • Peter MacCallum - Box Hill Hospital

    Box Hill, Victoria, 3128

  • Peter MacCallum - Moorrabbin

    East Bentleigh, Victoria, 3165

  • Andrew Love Cancer Care Centre, Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 8006

  • Royal Perth Hospital

    Perth, Western Australia, 6001

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Radiation Oncology - Mater Centre

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    Sydney, New South Wales, 2069

  • North Queensland Oncology Service

    Townsville, Queensland, 4810

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada8 sites

  • Cross Cancer Centre

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Centre of Southeastern Ontario Kingston

    Kingston, Ontario, K7L 5P9

  • Grand River Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Hotel-Dieu de Quebec

    Québec, G1R 2J6

  • Saint John Regional Hospital - Atlantic Health Sci

    Saint John, New Brunswick, E2L 4L2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Cancer Care Manitoba Winnipeg

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

New Zealand1 site

  • Christchurch Hospital

    Christchurch, 4710

Other trials in New Zealand

United Kingdom1 site

  • Princess Royal Hospital

    Hull

Other trials in United Kingdom

About this study

Official title: 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.

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.

Read the detailed description

Prospective radical treatment trials in oesophageal cancer have shown responses in both radiotherapy alone and radiotherapy when combined with chemotherapy. Retrospective studies show a response in the palliative setting to relieve dysphagia. The response, durability and quality of life end points have not been previously fully documented. This will be addressed by this trial.

Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus. Difficulty eating not only affects the patient's ability to maintain nutrition, but also impacts on all areas of quality of life. Relief of dysphagia becomes the highest priority for treatment.

At the time of developing this protocol there were no randomised trials comparing chemo-radiotherapy and radiotherapy in the palliative setting.

Few studies have prospectively assessed quality of life data for patients with oesophageal cancer, and although toxicity and survival data is available, there is no long-term data on quality of life. This trial will assess quality of life in a consecutive manner using a standardised self-reporting measure of quality of life, and compare quality of life across two groups having different treatments.

Eligible patients are those with proven carcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.

Patients will be randomised to the following treatment options:

  1. Radiotherapy Alone
  • 35 Gy in 15 fractions (Australia and New Zealand) or
  • 30 Gy in 10 fractions(Canada ONLY)
  1. Chemo-Radiotherapy
  • 35 Gy in 15 fractions (Australia and New Zealand) or
  • 30 Gy in 10 fractions (Canada ONLY)
  • Cisplatin 80mg/m2 IV day 1 (or 20mg/m2/day IV days 1 - 4)
  • 5-Fluorouracil 800mg/m2/day IV days 1 - 4

Patients will have an initial baseline assessment then be followed up weekly during treatment, monthly for 1 year post treatment and then 3 monthly.

Being tested
Cisplatin, Radiotherapy, 5-Fluorouracil
Keywords
Oesophageal, Dysphagia, Palliation, Quality of Life, Radiotherapy, Chemotherapy
Medical subject headings
Esophageal Neoplasms, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Cisplatin Injection

    80mg/m2 IV day 1

  • RadiotherapyRadiation

    Also called Radiation, Radiation Therapy

    35 Gy in 15 fractions

  • 5-FluorouracilDrug

    Also called DBL Flurouracil Injection BP, Efudix

    800mg/m2/day IV days 1 - 4

Study groups in NCT00193882
Study groupRoleWhat they receive
A: RadiotherapyActive comparatorRadiotherapy alone
Receives: Radiation: Radiotherapy
B: Chemo-radiotherapyExperimentalChemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
Receives: Drug: Cisplatin; Radiation: Radiotherapy; Drug: 5-Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relief of dysphagia

    Measured: This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.

Secondary outcomes (7)

  1. Dysphagia progression free survival.

    Measured: This will be measured from randomisation to the time of first progression of dysphagia.

  2. Quality of Life differences post treatment and at 3 months and 6 months.

    Measured: post treatment and at 3 months and 6 months.

  3. Acute and late toxicity.

    Measured: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

  4. Survival.

    Measured: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

  5. Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point dysphagia scale.

    Measured: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

  6. Number of patients receiving secondary treatment (radiation, chemotherapy or stenting).

    Measured: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

  7. Time to achieving a complete response i.e. dysphagia score of 0.

    Measured: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study start7 Jul 2003
  3. Primary completion21 Mar 2012
  4. Study completion18 Jun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193882
Sponsor's protocol ID
TROG 03.01
Other IDs
NCIC CTG ES.2, TGA 2004/83, NHMRC 291103
Status last verified
Jul 2017
First submitted
13 Sep 2005
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Penniment 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.

    PubMed 29248399

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Radiotherapy and 5-Fluorouracil in people with Esophagus Cancer, run by Trans Tasman Radiation Oncology Group at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Australia, Canada, New Zealand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relief of dysphagia (time frame: This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00193882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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