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Pancreatic CancerPhase 2NCT02461836

Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

A Phase 2 study testing Gemcitabine and SBRT in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is the only curable method to treat pancreatic cancer. However, even if radical resection is achieved, the 5-year survival rate is still low because of tumor recurrence. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
513 participants
Where
1 siteChina
Study dates
Aug 2015to Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/Female subjects, age ≥ 18 years and ≤ 75 years old at the time informed consent is signed
  • Pathologically confirmed pancreatic adenocarcinoma or mixed-type pancreatic carcinoma (adenocarcinoma predominantly)
  • The operation must be radical resection (R0), with all margins negative.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-2
  • Without large volume ascites or pleural effusion
  • Lab tests:
Show all 12Show fewer
  • a Complete blood cell count: HGB≥100g/L, WBC≥4×109/L, PLT≥100×109/L b Liver function: Total bilirubin≤3 x upper limit of normal range (ULN) with direct bilirubin within normal range, alanine aminotransferase (ALT) / aspartate aminotransferase (AST)≤3 c Renal function: Creatine≤1.5 x ULN or creatine clearance≥60 ml/min
  • Heart and lung function well (Eject function>55%)
  • Females of child-bearing potential must demonstrate a negative serum pregnancy test result at screening confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of Gemcitabine.
  • At least 30 days from major surgery before randomization, with full recovery
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  • Able to adhere to the study visit schedule and other protocol requirements

Who cannot join

  • Margin positive resections (R1 or R2)
  • Resection of recurrence pancreatic cancer
  • Other types of pancreatic cancer (non-adenocarcinoma)
  • Subjects with severe complications, can't tolerate chemotherapy in 4-12 weeks after surgery
  • Subjects with severe bone marrow suppression
  • Subjects with a history of severe lung diseases (interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis), severe liver diseases (active hepatitis, liver cirrhosis), renal dysfunction, uncontrolled diabetes and hypertension, or multiple and severe allergies which may lead to serious complications
Show all 15Show fewer
  • Subjects with severe heart diseases (congested heart failure, systematic coronary disease, uncontrolled arrhythmia, or myocardial infarction in 6 months)
  • Under treatment with steroids for a long time
  • Subjects with early recurrence of pancreatic cancer before initiation of chemotherapy
  • Subjects with diarrhea and infection (body temperature >38.5℃)
  • Subjects who was enrolled into another clinical study or finished another clinical study within the previous 4 weeks prior to randomization
  • Pregnant or nursing women
  • Subjects with other type of malignancies, except of curated basal cell carcinoma and carcinoma in situ of cervix which finished treatments more than half one year ago
  • Subjects having any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent them from participating in the study
  • Any condition that confounds interpreting data from the study

Trial locations and contacts

1 site in 1 country.

Tingbo Liang, MD PHD contact

0571-87315006

liangtingbo@zju.edu.cn

China1 site, 1 recruiting

  • the second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

    Tao Ma, MD,PhD, +8613857148997, zjumatao@gmail.com

    Recruiting

Other trials in China

About this study

Official title: An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is the only curable method to treat pancreatic cancer. However, even if radical resection is achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts.

The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

Read the detailed description

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Despite of the dramatic progress of diagnostic methods and surgical technics, the overall 5-year survival is still around 5%. Resection is the only curable method to treat pancreatic cancer, although only a small proportion of patients are eligible for operation. However, even if radical resection is achieved, the 5-year survival rate is only 15-20%. The main cause of death is tumor recurrence, which is as high as 50-70% in 3 years after operation. By now, it is widely accepted that pancreatic cancer is a systemic disease. Systemic treatments are recommended in neoadjuvant and adjuvant manners. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery, especially for patients who undergo a R1 (microscopic positive margin) and R2 (macroscopic positive margin) resection. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. Some argues adjuvant radiation after radical resection makes no effect on preventing local recurrence and metastasis but may impair patients' quality of life and overall survival. On the contrary, some other researchers draw the conclusion that adjuvant radiation may facilitate the local control of tumor recurrence in small cohorts. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts.

Traditionally, radiation may take more than one month to deliver and the dosage is restricted to prevent damage to surrounding tissues. The size effects and duration impair patients' compliance. Recently, the application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. The advantages of SBRT are higher dosage of radiation, less damage to surrounding organs, and significant reduce of duration. To our knowledge, there is no big randomized clinical trial to evaluate the value of SBRT for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1). It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

Being tested
Gemcitabine, SBRT
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GemcitabineDrug

    Also called GEM

    Protocol: Gemcitabine 1000mg/m2.body surface area (BSA), IV infusion for at least 30 mins, administered at Day1, Day8, Day15)

  • SBRTRadiation

    Also called Radio

    Protocol: 5 Gy/d, for 5 consecutive days

Study groups in NCT02461836
Study groupRoleWhat they receive
ChemoExperimentaladjuvant chemotherapy using Gemcitabine for 6 rounds
Receives: Drug: Gemcitabine
Chemo+SBRTExperimentalSBRT is delivered prior to adjuvant chemotherapy with Gemcitabine for 6 rounds
Receives: Drug: Gemcitabine; Radiation: SBRT

What is being measured

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

  1. disease-free survival (DFS)

    Measured: Up to approximately 36 months

Secondary outcomes (3)

  1. overall survival (OS)

    Measured: Up to approximately 60 months

  2. quality of life (QOL) as assessed by the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PAN26 score

    Measured: Up to approximately 60 months

  3. safety as assessed according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

    according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

    Measured: Up to approximately 8 months

Timeline

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

  1. First posted3 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
513 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461836
Sponsor's protocol ID
YAN2015-030
Status last verified
Apr 2017
First submitted
28 May 2015
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ma T, Bai X, Wei Q, Shui Y, Lao M, Chen W, Huang B, Que R, Gao S, Zhang Y, Chen W, Wang J, Liang T. Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial. BMC Cancer. 2022 Aug 8;22(1):865. doi: 10.1186/s12885-022-09974-7.

    PubMed 35941566

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and SBRT in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 12 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Apr 2017. 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 China. 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?

Results are not available in the source record.

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

Contact Tingbo Liang, MD PHD (0571-87315006, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (DFS) (time frame: Up to approximately 36 months). 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 NCT02461836, 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 5 Apr 2017.

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