Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01781728

Collaborator

(none)

120

Enrollment

Location

Arms

120

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Periampullary Adenocarcinoma	Radiation: Stereotactic Body Radiation Therapy (SBRT) Radiation: Stereotactic Body Radiation Therapy (SBRT)	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RT naive	Radiation: Stereotactic Body Radiation Therapy (SBRT) SBRT 6.6 Gy x 5 (over 1-2 weeks)* Other Names: SBRT
Active Comparator: Previous RT	Radiation: Stereotactic Body Radiation Therapy (SBRT) SBRT 5 Gy x 5 (over 1-2 weeks)* Other Names: SBRT

Arm

Intervention/Treatment

Active Comparator: RT naive

Radiation: Stereotactic Body Radiation Therapy (SBRT)

SBRT 6.6 Gy x 5 (over 1-2 weeks)*

Other Names:

SBRT

Active Comparator: Previous RT

Radiation: Stereotactic Body Radiation Therapy (SBRT)

SBRT 5 Gy x 5 (over 1-2 weeks)*

Other Names:

SBRT

Outcome Measures

Primary Outcome Measures

Late GI toxicity [greater than 3 months after treatment]
grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity

Secondary Outcome Measures

Acute GI toxicity [within 3 months of treatment]
Any gastrointestinal (GI) toxicities grade 3 or greater.
Local progression free survival [3, 6, and 12 months after treatment]
Local progression free survival rate at 3, 6, and 12 months..
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.
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.
Linac based SBRT standardization [3, 6, and 12 months after treatment]
To develop and standardize Linac based SBRT delivery and dosimetric parameters
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.
Health related Quality of Life (QoL) [3, 6 and 12 months after treatment then annually thereafter]
To evaluate health-related quality of life (QoL) before and after SBRT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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