Phase II study of fixed dose rate Gemcitabine-Oxaliplatin Integrated with concomitant 5FU and 3-D Conformal Radiotherapy for the treatment of localised pancreatic cancer: GOFURTGO

Phase 2

Completed

• Conditions: ocally advanced or locally recurrent inoperable pancreatic cancer not previously treated with chemotherapy or radiotherapy.; Locally advanced or locally recurrent inoperable pancreatic cancer not previously treated with chemotherapy or radiotherapy.; Cancer - Pancreatic

• Registration Number: ACTRN12605000026628
• Lead Sponsor: AGITG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Patient must have histologically/cytologically proven adenocarcinoma of the pancreas located in the head or the body of the pancreas (primary) or in the pancreatic bed (locally recurrent).Locoregional disease must be confirmed by dual phase CT (arterial and portal phases) without distant metastases (confirmed by CT of the chest, abdomen and pelvis).Patients must be assessed by a surgeon and considered inoperable.Performance status must be ECOG grade 0, 1 or 2.

Exclusion Criteria

1.Histological types other than pancreatic ductal adenocarcinoma
2. Metastatic disease.
3. Tumours of the tail of pancreas
4. Major co-morbid illnesses that, in the opinion of the investigator, would jeopardise the likely completion of the treatment program
5. Patients with peripheral sensory neuropathy with functional impairment.
6. Derangement of LFTs consistent with hepatic cellular dysfunction (ALT and/or AST >3 times upper limit of normal), or a bilirubin >3 times upper limit of normal. Patients with LFTs consistent with hepatic obstruction that is relieved (eg. by stenting, bypass) are eligible, provided the bilirubin has fallen to <3 times upper limit of normal.
7. Patients with significant loss of bodyweight, who, at the investigator’s discretion, is deemed not suitable for this study (eg.>15% weight loss since surgery or diagnosis)
8. Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
9. Treatment with any previous cytotoxic chemotherapy for this malignancy. Previous hormonal manipulation (including HRT) is allowed.
10. Previous abdominal radiotherapy
11. A previous history of malignancy other than non-melanomatous skin cancers, in –situ carcinoma, or patients who are disease–free from non-pancreatic tumours treated definitively more than 5 years ago.
12. Pregnant or lactating women, or women of childbearing potential not using adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine the proportions of patients starting and finishing greater than or equal to 80% of the planned dose on time for each component of the treatment.[The outcome will be measured once all patients have enrolled and have completeed the study treatment.]

Secondary Outcome Measures

Name	Time	Method
Adverse events[Assessed at the end of ecah treatment cycle, and at end of treatment.];Objective tumour response rates[Before and after radiotherapy, at the end of treatment, and then as clinically indicated.];Time to progression[Before and after radiotherapy, at the end of treatment, and then as clinically indicated.];CA 19-9 response rates[Before and after radiotherapy, at the end of treatment, and then 2 monthly during follow up.];Health-related quality of life.[Before and after radiotherapy, at the end of treatment, and then 2 monthly until progression/disease recurrence.]