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Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Primary Purpose

Pancreatic Cancer, Periampullary Adenocarcinoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional health services research trial for Pancreatic Cancer focused on measuring recurrent, unresectable, residual, stereotactic body radiation therapy (SBRT), palliative management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

RT naive

Previous RT

Arm Description

Outcomes

Primary Outcome Measures

Late GI toxicity

grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity

Secondary Outcome Measures

Acute GI toxicity

Any gastrointestinal (GI) toxicities grade 3 or greater.

Local progression free survival

Local progression free survival rate at 3, 6, and 12 months..

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.

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.

Linac based SBRT standardization

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

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

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)

To evaluate health-related quality of life (QoL) before and after SBRT.

Full Information

NCT ID

NCT01781728

First Posted

August 8, 2012

Last Updated

May 30, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT01781728

Brief Title

Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 1, 2013 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Periampullary Adenocarcinoma

Keywords

recurrent, unresectable, residual, stereotactic body radiation therapy (SBRT), palliative management

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RT naive

Arm Type

Active Comparator

Arm Title

Previous RT

Arm Type

Active Comparator

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Other Intervention Name(s)

SBRT

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Other Intervention Name(s)

SBRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Late GI toxicity

Description

grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity

Time Frame

greater than 3 months after treatment

Secondary Outcome Measure Information:

Title

Acute GI toxicity

Description

Any gastrointestinal (GI) toxicities grade 3 or greater.

Time Frame

within 3 months of treatment

Title

Local progression free survival

Description

Local progression free survival rate at 3, 6, and 12 months..

Time Frame

3, 6, and 12 months after treatment

Title

Linac based SBRT pain control

Description

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.

Time Frame

3, 6, and 12 months after treatment

Title

FDG-PET use for planning and estimation of survival

Description

To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.

Time Frame

3, 6, and 12 months after treatment and then annually thereafter

Title

Linac based SBRT standardization

Description

To develop and standardize Linac based SBRT delivery and dosimetric parameters

Time Frame

3, 6, and 12 months after treatment

Title

Toxicity and outcomes for patients with chemotherapy, with or without surgery and radiation for tumor assessments

Description

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.

Time Frame

3, 6, and 12 months after treatment and then annually thereafter

Title

Toxicity and outcomes for chemotherapy only and radiation

Description

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.

Time Frame

3, 6, and 12 months after treatment and then annually thereafter

Title

Health related Quality of Life (QoL)

Description

To evaluate health-related quality of life (QoL) before and after SBRT.

Time Frame

3, 6 and 12 months after treatment then annually thereafter

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amol Narang, M.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

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Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

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