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NCT Number: NCT01781728

Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Periampullary Adenocarcinoma Recurrence

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy (SBRT)

Radiation

Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy.

Primary outcomes

  1. Late Gastrointestinal Toxicities

    Time frame: 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 outcomes

  1. Acute Gastrointestinal Toxicity

    Time frame: within 3 months of treatment

    Any acute gastrointestinal (GI) toxicities grade 3 or greater.

  2. Local Progression Free Survival From SBRT

    Time frame: 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.

  3. Local Progression Free Survival From Diagnosis

    Time frame: 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.

  4. Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)

    Time frame: 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.

  5. Linear Accelerator (Linac) Based SBRT Pain Control

    Time frame: 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.

  6. Linac Based SBRT Standardization

    Time frame: 3, 6, and 12 months after treatment

    To develop and standardize Linac based SBRT delivery and dosimetric parameters

  7. FDG-PET Use for Planning and Estimation of Survival

    Time frame: 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.

  8. Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments

    Time frame: Up to 36 months

    Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

  9. Toxicity for Patients With Chemotherapy and Radiation (no Resection)

    Time frame: Up to 36 months

    Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma

Important dates

Study start
2013
Primary completion
2021
Study completion
2024
First posted
Feb 1, 2013
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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