Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant chemoradiotherapy | Experimental | 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. |
|
| adjuvant chemotherapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant chemoradiotherapy | Combination Product | Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression free survival will be determined. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival will be determined. | The time from the randomization to death. | 3 years |
| Treatment-related adverse events will be determined. | Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Zhu | Contact | 86-021-31162222 | zhuxiaofei_zxf@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huojun Zhang, M.D. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huojun Zhang | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40583350 | Derived | Zhu X, Liu W, Jiang L, Cao Y, Ye Y, Yu C, Yin X, Zhang H. ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer. Future Oncol. 2025 Aug;21(18):2269-2273. doi: 10.1080/14796694.2025.2522061. Epub 2025 Jun 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059186 | Chemoradiotherapy, Adjuvant |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adjuvant chemotherapy | Drug | Chemotherapy (gemcitabine plus capecitabine) |
|
| 3 years |
| Quality of life will be determined. | 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011878 |
| Radiotherapy |