CompletedPhase 3ACTRN12606000526572

Advanced oesophageal cancer study to compare quality of life and palliation of dysphagia

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).


Sponsor

Trans Tasman Radiation Oncology Group

Enrollment

220 participants

Start Date

Jul 7, 2003

Study Type

Interventional

Conditions

Summary

People with cancer of the oesophagus (gullet) often have trouble swallowing. Radiotherapy can help improve this problem. Using chemotherapy together with radiotherapy may work better but has more side effects. This trial will determine if it is better to use radiotherapy by itself or together with chemotherapy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria10

  • 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 sollids (see appendix 1)
  • Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
  • Patients msut begin treatment within 2 weeks of randomisation
  • Patient is at least 18 years old
  • Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L
  • Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1).
  • Patients capable of child bearing are using adequate contraception.
  • Written informed consent of patient.

Exclusion Criteria9

  • 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.
  • Previous chemotherapy for Oesophageal Cancer
  • CT scan of thorax and abdomen more than 8 weeks prior to randomisation
  • Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation

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Interventions

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 squa

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)


Locations(3)

Canada

New Zealand

United Kingdom

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ACTRN12606000526572