Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Adjuvant chemoradiotherapy

Intervention Type COMBINATION_PRODUCT

Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)

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.

Group Type ACTIVE_COMPARATOR

Adjuvant chemotherapy

Intervention Type DRUG

Chemotherapy (gemcitabine plus capecitabine)

Interventions

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Adjuvant chemoradiotherapy

Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)

Intervention Type COMBINATION_PRODUCT

Adjuvant chemotherapy

Chemotherapy (gemcitabine plus capecitabine)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No