Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01781728
• Other study ID #: J1273
• Secondary ID: NA_00070233
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2013
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Periampullary Adenocarcinoma

Intervention

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
SBRT 5 Gy x 5 (over 1-2 weeks)*
• Stereotactic Body Radiation Therapy (SBRT)
SBRT 6.6 Gy x 5 (over 1-2 weeks)*

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late GI toxicity	grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity	greater than 3 months after treatment
Secondary	Acute GI toxicity	Any gastrointestinal (GI) toxicities grade 3 or greater.	within 3 months of treatment
Secondary	Local progression free survival	Local progression free survival rate at 3, 6, and 12 months..	3, 6, and 12 months after treatment
Secondary	Linac based SBRT pain control	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.	3, 6, and 12 months after treatment
Secondary	FDG-PET use for planning and estimation of survival	To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.	3, 6, and 12 months after treatment and then annually thereafter
Secondary	Linac based SBRT standardization	To develop and standardize Linac based SBRT delivery and dosimetric parameters	3, 6, and 12 months after treatment
Secondary	Toxicity and outcomes for patients with chemotherapy, with or without surgery and radiation for tumor assessments	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.	3, 6, and 12 months after treatment and then annually thereafter
Secondary	Toxicity and outcomes for chemotherapy only and radiation	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.	3, 6, and 12 months after treatment and then annually thereafter
Secondary	Health related Quality of Life (QoL)	To evaluate health-related quality of life (QoL) before and after SBRT.	3, 6 and 12 months after treatment then annually thereafter