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Pancreatic CancerPhase 2NCT01494155

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

A Phase 2 study testing Capecitabine, Hydroxychloroquine and Proton or Photon Radiation Therapy in people with Pancreatic Cancer, run by Massachusetts General Hospital at 1 site 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 patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine… 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?
Capecitabine, Hydroxychloroquine and Proton or Photon Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
27 Dec 2011to 16 Sep 2018
Phase
Phase 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 or histologic proof of pancreatic ductal carcinoma
  • Life expectancy > 3 months
  • Adequate organ and marrow function

Who cannot join

  • Evidence of metastatic disease
  • Pregnant or breast-feeding
  • Tumors in the body or tail of the pancreas
  • Serious concomitant systemic disorders such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifest by fever
  • Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
  • Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed.
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  • Other serious uncontrolled medical conditions
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier). Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD deficiency
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • 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
  • Currently taking cimetidine
  • Receiving any other study agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine and HCQ
  • Already taking HCQ or chloroquine for other diagnosis
  • History of Grade 3 or greater retinopathy or keratitis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine.

In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.

Read the detailed description

Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end.

Capecitabine will be taken orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital.

The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine.

Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).

Being tested
Capecitabine, Hydroxychloroquine, Proton or Photon Radiation Therapy
Keywords
resectable pancreatic cancer, pancreaticoduodenectomy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

    825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)

  • HydroxychloroquineDrug

    Also called Plaquenil

    400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital

  • Proton or Photon Radiation TherapyRadiation

    Daily, beginning Week 2 for 5 consecutive days

Study groups in NCT01494155
Study groupRoleWhat they receive
HydroxychloroquineExperimentalHydroxychloroquine with chemoradiation
Receives: Drug: Capecitabine; Drug: Hydroxychloroquine; Radiation: Proton or Photon Radiation Therapy

What is being measured

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

  1. Progression-free Survival

    Progression-free survival (PFS) will be defined as the time from the start of treatment until the first objective documentation of progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death. PFS is reported as the number of participants without PD after 2 years and 4 years on study. Participants who die without a reported prior progression will be considered to have progressed on the day of their death.

    Progressive disease (PD) is defined as at least a 20% increase in the sum of longest the diameters of target lesions, taking as reference the baseline sum diameters. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: up to 4 years

Secondary outcomes (7)

  1. Number of Participants With Pathologic Complete Response

    Pathological complete response (pCR) will be defined as the absence of any viable tumor cells within the tissue samples removed during surgery.

    Measured: up to 9 weeks

  2. Overall Survival

    Overall survival (OS) is defined as the time from start of study therapy to date of death and will be reported as the number of patients alive after 2 years and 4 years on study. Participants who have not died will be censored at the date they were last known to be alive.

    Measured: up to 4 years

  3. Treatment-Emergent Adverse Events

    Treatment-emergent adverse events (TEAEs) are grade 3 or higher AEs as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4, and at least possibly related to study treatment capecitabine + hydroxychloroquine and short course radiation therapy. TEAEs are AEs that began after the start of study treatment; or if the event was continuous from baseline and was serious, at least possibly related to study treatment, or resulted in death, discontinuation, or interruption or reduction of study treatment. Participants with multiple occurrences of TEAEs are counted only once per specific category in CTCAE v4.

    Measured: 3 weeks

  4. Number of Participants With Surgical Morbidity

    Surgical morbidity is defined as adverse events during an operation and up to 30 days afterwards, grade 3 or higher and at least possibly related to surgery as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.

    Measured: up to 30 days after surgery

  5. Number of Participants With Post-operative Mortality

    Post-operative mortality is defined as death within 30 days after surgery.

    Measured: 30 days after surgery

  6. Number of Participants With Pathologic Downstaging

    Pathologic downstaging (pDS) is defined as a change in the tumor stage from pre-treatment clinical staging to the final pathology of the surgically removed tumor after receiving neoadjuvant treatment (i.e., treatment given before surgery).

    Measured: up to 9 weeks

  7. Number of Participants With Local Control

    Local control is defined as the time from the start of study treatment to the date of local failure; this outcome is reported below as the number of participants without local failure at 2 years after start of study treatment. Local failure is defined as progressive disease (PD) of the main tumor or at the margins of where the main tumor was surgically removed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 below:

    • At least a 20% increase in the longest diameter of target tumor lesion and an absolute increase of at least 5 mm, taking as reference the baseline measurement.
    • The appearance of one or more new lesions is also considered progression.

    Patients who have not experienced a local failure will be censored at the last date they were known to have local control.

    Measured: Up to 2 years

Timeline

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

  1. First posted16 Dec 2011 (estimated)
  2. Study start27 Dec 2011
  3. Primary completion16 Sep 2018
  4. Study completion16 Sep 2018

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494155
Sponsor's protocol ID
11-073
Status last verified
Dec 2025
First submitted
29 Jul 2011
Last updated
5 Aug 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Hydroxychloroquine and Proton or Photon Radiation Therapy in people with Pancreatic Cancer, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 18 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 5 Aug 2026). 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?

Progression-free Survival (time frame: up to 4 years). 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 NCT01494155.

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 5 Aug 2026.

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