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Phase II Study of Weekly Oxaliplatin With Continous Infusion Fluorouracil And Concurrent Radiation for Treatment of Localised Oesophageal Carcinoma

Phase II Study of Weekly Oxaliplatin With Continous Infusion Fluorouracil And Concurrent Radiation for Treatment and to determine response and local control of Localised Oesophageal Carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000106639
Enrollment
30
Registered
2005-08-09
Start date
2003-12-04
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Oxaliplatin is designated chemically as [SP-4-2]-(1R,2R)-(cyclohexane-1,2-diamine-k2N,Nÿ¿ÿ´ (oxalato(2-)-k2O1,O2]platinum (II) given by intravenous infusion. This is a single arm open label Phase II study of chemo-radiation of localised oesophageal cancer with Oxaliplatin, continuous infusion fluorouracil and radiation. The duration of the study participation will include for each patient a 1 week inclusion and treatment planning period, followed by a 6 week treatment period, followed by a

Oxaliplatin is designated chemically as [SP-4-2]-(1R,2R)-(cyclohexane-1,2-diamine-k2N,Nÿ¿ÿ´ (oxalato(2-)-k2O1,O2]platinum (II) given by intravenous infusion. This is a single arm open label Phase II study of chemo-radiation of localised oesophageal cancer with Oxaliplatin, continuous infusion fluorouracil and radiation. The duration of the study participation will include for each patient a 1 week inclusion and treatment planning period, followed by a 6 week treatment period, followed by a minimum of 1 week follow-up for chemotherapy related toxicities after the completion of the study treatment. In addition all patients will be followed for radiation toxicity and disease status for 2 years after the completion of the study treatment. Treatment Regimen: *5-fluorouracil via continuous intravenous infusion at the dose of 225mg/m2/day commencing on first day of radiation and continuing until delivery of last radiation fraction. *Oxaliplatin given by 2-hour intravenous infusion at a dose of 60mg/m2 weekly commencing immediately prior to the commencement of 5-fluorouracil Radiation-Standard total 54 to 60 Gy, given daily apart from weekends and public holidays

Sponsors

Princess Alexandra Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1.Histologically confirmed localised squamous cell carcinoma of the oesophagus or adenocarcinoma of the oesophagus. 2. Performance status 0 or 1. 3. No prior chemotherapy or radiotherapy. 4. Disease evaluated by either CT or endoscopy. 5. Geographically accessible. 6. No other severe medical illness which would contra-indicate the therapy. 7. Life expectancy of greater than 3 months. 8. Bone marrow function showing white cells greater than 3.0x109/L, neutrophils greater than 2.0x109/L, platelets greater than 100x109/L. 9. Creatinine less than 2x upper limit of normal. 10.Adequate methods of contraception.

Exclusion criteria

1. Serious uncontrolled infection 2. Uncontrolled other malignancy 3. Concurrent treatment with other anti-cancer drugs 4. Respiratory function with FEV1 less than 1L 5. Oesophageal-bronchial fistula 6. Pregnancy or Lactation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026