Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC) (ADJUPANC)

January 31, 2025 updated by: Zhang Huo Jun, Changhai Hospital

Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer

In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.

Study Type

Interventional

Enrollment (Estimated)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Huojun Zhang
        • Contact:
        • Contact:
          • Huojun Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75 years
  • Pathologically confirmed pancreatic ductal adenocarcinoma
  • Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
  • No history of cancer treatment after surgical resection
  • No disease progression confirmed by imaging examinations
  • ECOG 0 to1 point
  • No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)

Exclusion Criteria:

  • History of cancer treatment after surgical resection
  • History of other cancers within 5 years
  • Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
  • ECOG ≥2 points
  • Significant abnormality in blood routine test, liver and kidney function test and coagulation test
  • Active inflammatory bowel disease
  • Gastrointestinal bleeding or perforation within 6 months
  • Infections requiring antibiotics
  • Heart or respirotory insufficiency
  • Pregnant women or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adjuvant chemoradiotherapy

Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.

Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 1650mg/m2，bid.
Combination product: Adjuvant chemoradiotherapy
Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
Active Comparator: adjuvant chemotherapy
Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
Drug: Adjuvant chemotherapy
Chemotherapy (gemcitabine plus capecitabine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression free survival will be determined.
Time Frame: 3 years
The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival will be determined.
Time Frame: 3 years
The time from the randomization to death.
3 years
Treatment-related adverse events will be determined.
Time Frame: 3 years
Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
3 years
Quality of life will be determined.
Time Frame: 3 years
The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Huojun Zhang, M.D., Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 19, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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