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Pancreatic CancerPhase 1/2NCT00438256

Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

A Phase 1/2 study testing Proton Beam Radiation and Capecitabine in people with Pancreatic Cancer, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Proton Beam Radiation and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Dec 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologic of histologic proof of pancreatic ductal carcinoma
  • No evidence of metastatic disease
  • 18 years of age or older
  • ECOG Performance Status of 0 or 1 - Lab values as outlined in the protocol

Who cannot join

  • Tumors in the body or tail of the pancreas
  • Hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
  • Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, ongoing infection as manifested by fever
  • Pregnant or lactating women
  • Life expectancy of < 3 months
  • Serious, uncontrolled, concurrent infection (s)
Show all 17Show fewer
  • Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
  • Clinically significant cardiac disease or myocardial infarction within the last 12 months
  • Other serious uncontrolled medical condition that the investigator feels might compromise study participation
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Any prior fluoropyrimidine therapy
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to a 5-fluorouracil or known DPD deficiency
  • Participation in any investigational drug study within 4 weeks preceding the start of the study
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability
  • Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
  • Patients on cimetidine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.

Read the detailed description
  • Not everyone who participates in this research study will receive the same schedule of radiation therapy. The schedule of radiation therapy will depend on the number of participants enrolled on the study and how well they have tolerated their radiation schedule. All patients will receive proton beam therapy.
  • Here are the proposed schedules of radiation therapy. If at any point too many subjects experience too many unacceptable side effects, no subject will be enrolled to the next level. Dose Level 1: 10 radiation sessions given Monday-Friday for two weeks. Dose Level 2: 5 radiation sessions given Monday, Wednesday and Friday in Week 1 and Tuesday and Thursday in Week 2. Dose Level 3: 5 radiation sessions given Monday, Tuesday, Thursday and Friday in Week 1 and Monday in Week 2. Dose Level 4: 5 Radiation sessions given Monday through Friday in Week 1.
  • In Dose Levels 2, 3 and 4, there are fewer radiation sessions, but the radiation dose given at each session is slightly higher than the dose given in each of the 10 sessions of Dose Level 1.
  • Capecitabine will be given orally (pill form) starting on the first day of radiation therapy and will be taken for the two weeks that the participant receives radiation therapy.
  • On days 1, 8 and 15 of each study cycle, the participant will be seen at the clinic for: physical examination, questions about side effects; and routine blood tests.
  • After the last day of study treatment there will be up to a six-week rest period before surgery is performed.
  • About three to six weeks after the participant has finished study treatment, the following procedures will be done: CT or MRI, physical examination; questions about side effects and blood tests.
Being tested
Proton Beam Radiation, Capecitabine
Keywords
accelerated short course, proton beam radiation
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton Beam RadiationProcedure or surgery

    Given over different schedules and duration

  • CapecitabineDrug

    Given orally starting on day one of radiation therapy for 2 weeks

Study groups in NCT00438256
Study groupRoleWhat they receive
Group 1Experimental10 Radiation Sessions over 2 weeks
Receives: Procedure: Proton Beam Radiation; Drug: Capecitabine
Group 2Experimental5 Radiation sessions: 3 in week 1 and 2 in week 2
Receives: Procedure: Proton Beam Radiation; Drug: Capecitabine
Group 3Experimental5 Radiation sessions: 4 in week 1 and 1 in week 2
Receives: Procedure: Proton Beam Radiation; Drug: Capecitabine
Group 4Experimental5 Radiation Sessions in one week
Receives: Procedure: Proton Beam Radiation; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm

    The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:

    1. Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or
    2. Any grade 4 non-hematologic toxicity or
    3. Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)

    Measured: 3 Weeks

  2. Number of Participants With Grade 3 or Greater Toxicity in Phase II

    Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity.

    Measured: 30 days after the end of treatment, up to approximately 6 months total

Secondary outcomes (5)

  1. Number of Participants With a Pathological Complete Response

    All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.

    Measured: at the time of surgery (28-42 days after start of treatment)

  2. Median Progression Free Survival

    The median amount of time from the start of treatment until death or disease progression, whichever occurs first.

    Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline.

    Measured: from the start of treatment until death or progression, median duration of 10.4 months

  3. Number of Participants With Surgical Morbidity

    Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery

    Measured: 30 days post surgery (surgery was 28-42 days after the start of treatment)

  4. 30-Day Post Operative Mortality

    The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.

    Measured: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment)

  5. Number of Participants With Treatment Related Serious Adverse Events

    The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment.

    Measured: From the start of treatment until 30 days after the end of treatment, up to approximately 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00438256
Sponsor's protocol ID
06-248
Status last verified
Dec 2018
First submitted
20 Feb 2007
Last updated
23 Jan 2019
Data monitoring committee
Yes

Publications

  • Hong TS, Ryan DP, Borger DR, Blaszkowsky LS, Yeap BY, Ancukiewicz M, Deshpande V, Shinagare S, Wo JY, Boucher Y, Wadlow RC, Kwak EL, Allen JN, Clark JW, Zhu AX, Ferrone CR, Mamon HJ, Adams J, Winrich B, Grillo T, Jain RK, DeLaney TF, Fernandez-del Castillo C, Duda DG. A phase 1/2 and biomarker study of preoperative short course chemoradiation with proton beam therapy and capecitabine followed by early surgery for resectable pancreatic ductal adenocarcinoma. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):830-8. doi: 10.1016/j.ijrobp.2014.03.034. Epub 2014 May 24.

    PubMed 24867540

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Proton Beam Radiation and Capecitabine in people with Pancreatic Cancer, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm (time frame: 3 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00438256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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