Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Phase 2

Completed

Conditions: Periampullary Adenocarcinoma
Pancreatic Cancer

Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Registration Number: NCT01781728

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary: The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

Detailed Description: No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

18 years of age or older
Karnofsky Performance Status greater than or equal to 70%
confirmed pancreatic or periampullary adenocarcinoma
pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
Either:
- standard of care treatment for pancreatic cancer that included radiation therapy
  
  * patients may be receiving continued chemotherapy post initial CRT. or
- standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
acceptable organ and marrow function as determined by blood tests
ability to understand and give consent
must be a patient to be treated with SBRT only at Johns Hopkins Hospital
life expectancy of greater than 3 months

Exclusion Criteria

extensive metastatic disease
performance status of less than 70
children are excluded form the study
no uncontrolled intercurrent illness
no concurrent malignancy other than melanoma
pregnant or breast feeding women are excluded
women who are not post-menopausal and have a positive pregnancy test
life expectancy of less than 3 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma	Stereotactic Body Radiation Therapy (SBRT)	Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.

Primary Outcome Measures

Name	Time	Method
Late Gastrointestinal Toxicities	3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months	Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Secondary Outcome Measures

Name	Time	Method
Acute Gastrointestinal Toxicity	within 3 months of treatment	Any acute gastrointestinal (GI) toxicities grade 3 or greater.
Local Progression Free Survival From SBRT	From date of randomization until the date of first documented progression or death from any cause (up to 36 months).	Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.
Local Progression Free Survival From Diagnosis	From date documented diagnosis to date of first documented local disease progression.	Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.
Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)	Baseline (Pre-SBRT) and at 3 months (Post-SBRT)	To evaluate whether a change in patient reported quality of life (QoL) occurred between baseline (pre-SBRT) and at 3 months (post-SBRT) using the European Organization for Research and Treatment in Cancer quality of life core cancer questionnaire with the pancreatic cancer module (EORTC QLQ-C30/Pan26). This assessment is a multi-dimensional, 30-item questionnaire which assesses 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales ( fatigue, pain and nausea/vomiting), a global health/QoL scale as well as 6 single items. There are also 26 questions specific to patients with pancreatic cancer. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Linac Based SBRT Pain Control	3, 6, and 12 months after treatment	To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment.
Linac Based SBRT Standardization	3, 6, and 12 months after treatment	To develop and standardize Linac based SBRT delivery and dosimetric parameters
FDG-PET Use for Planning and Estimation of Survival	3, 6, and 12 months after treatment and then annually thereafter	To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.
Toxicity and Outcomes for Patients With Chemotherapy, With or Without Surgery and Radiation for Tumor Assessments	3, 6, and 12 months after treatment and then annually thereafter	To evaluate toxicity and outcomes among patients with recurrent or residual disease after previous chemoradiation therapy, with or without surgery, who will be treated with 5 Gy x 5.
Toxicity and Outcomes for Chemotherapy Only and Radiation	3, 6, and 12 months after treatment and then annually thereafter	To evaluate toxicity and outcomes among patients with recurrent or residual disease after chemotherapy only, (with or without surgery), who will be treated with 6.6 Gy x 5.