Stereotactic body radiation therapy pre-operatively for borderline resectable pancreatic cancer

Phase 1

Completed

• Conditions: Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas; Cancer

• Registration Number: ISRCTN14138956
• Lead Sponsor: niversity of Oxford

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27619800 protocol 2018 Abstract results in https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.4_suppl.TPS536 abstract 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33217498/ results (added 29/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-19
• Study Completion: 2019-03-01
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Current participant inclusion criteria as of 10/05/2018:
1. Borderline resectable localised tumour of the pancreatic head/uncinate process/body as per NCCN Guidelines (tumours of the tail of pancreas are not eligible for inclusion) or operable tumour in contact with or operable tumour in contact with, as defined by CT +/MRI +/PET criteria within 28+/7 days prior to trial entry de novo or following chemotherapy.
2. Histologically proven pancreatic ductal adenocarcinoma or cytological proven pancreatic malignancy
3. Able to undergo biliary drainage using a stent
4. Deemed fit and suitable for surgical resection
5. No overt metastases or uncertain status with investigations suspicious of possible metastatic disease (e.g. small equivocal pulmonary nodule(s)).
6. Male or female, Age = 16 years
7. Life expectancy of at least 6 months
7. ECOG performance status 0-1
8. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled followup visits and examinations
9. Written (signed and dated) informed consent and be capable of cooperating with protocol
10. Haematological and biochemical indices within given ranges

Previous participant inclusion criteria:
1. Borderline resectable localised tumour of the pancreatic head/uncinate process/body as per NCCN Guidelines (tumours of the tail of pancreas are not eligible for inclusion) as defined by CT +/MRI +/PET criteria within 28+/7 days prior to trial entry
2. Histologically proven pancreatic ductal adenocarcinoma or cytological proven pancreatic malignancy
3. Able to undergo biliary drainage using a stent
4. Deemed fit and suitable for surgical resection
5. Male or female, Age = 16 years
6. Life expectancy of at least 6 months
7. ECOG performance status 0-1
8. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled followup visits and examinations
9. Written (signed and dated) informed consent and be capable of cooperating with protocol
10. Haematological and biochemical indices within given ranges

Exclusion Criteria

Current participant exclusion criteria as of 10/05/2018:
1. Definite metastatic disease or local disease that cannot be encompassed in the SBRT field
2. History of previous or concurrent malignancy diagnoses for which the expected prognosis is likely to be worse than that of the current diagnosis of pancreatic cancer (excludes for example: e.g. localised prostate cancer, early colorectal cancer, early breast cancer, curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix; curatively treated cancer of other sites who are recurrence free for >3 years)
3. Serious medical or psychological condition precluding trial intervention
4. Previous upper abdominal or chest wall radiotherapy
5. Pregnancy. Pregnant or breastfeeding women or women of childbearing potential unless effective methods of contraception are used.
6. Any other psychological, social or medical condition, physical examination finding or laboratory abnormality that the Investigator considers makes the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of the trial results.

Previous participant exclusion criteria:
1. Distant metastatic disease or local disease that cannot be encompassed in the SBRT field
2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix; curatively treated cancer of other sites who are recurrence free for = 3 years)
3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection
4. Previous upper abdominal or chest wall radiotherapy
5. Pregnancy. Pregnant or breastfeeding women or women of childbearing potential unless effective methods of contraception are used
6. Any other psychological, social or medical condition, physical examination finding or laboratory abnormality that the Investigator considers makes the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of the trial results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 10/05/2018:<br> Maximum Tolerated Dose (MTD); Timepoint(s): 30 days post-surgery for patients proceeding to surgery or 3 months post SBRT for patients not proceeding to surgery.<br><br> Previous primary outcome measure:<br> Maximum Tolerated Dose (MTD); Timepoint(s): 30 days post-surgery<br>