## Protocol Section
### Identification Module
**NCT ID:** NCT06427447

**Acronym:** ADJUPANC

**Brief Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

**Official Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer

#### Organization Study ID Info
**ID:** CH hospital
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2029-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhai Hospital

#### Responsible Party

**Investigator Affiliation:** Changhai Hospital

**Investigator Full Name:** Zhang Huo Jun

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

**Keywords:**

- pancreatic cancer

- adjuvant chemoradiotherapy

- adjuvant chemotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 770

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/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, 825mg/m2，bid.

**Intervention Names:**

- Combination Product: Adjuvant chemoradiotherapy

**Label:** adjuvant chemoradiotherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.

**Intervention Names:**

- Drug: Adjuvant chemotherapy

**Label:** adjuvant chemotherapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- adjuvant chemoradiotherapy

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

**Name:** Adjuvant chemoradiotherapy

**Type:** COMBINATION_PRODUCT

#### Intervention 2

**Arm Group Labels:**

- adjuvant chemotherapy

**Description:** Chemotherapy (gemcitabine plus capecitabine)

**Name:** Adjuvant chemotherapy

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Disease progression free survival will be determined.

**Time Frame:** 3 years

#### Secondary Outcomes

**Description:** The time from the randomization to death.

**Measure:** Overall survival will be determined.

**Time Frame:** 3 years

**Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

**Measure:** Treatment-related adverse events will be determined.

**Time Frame:** 3 years

**Description:** 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.

**Measure:** Quality of life will be determined.

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 18-75 years
* Pathologically confirmed pancreatic ductal adenocarcinoma
* Pathologically confirmed lymph node metastasis, R1 or R2 resection or perineural 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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhuxiaofei_zxf@163.com

**Name:** Xiaofei Zhu

**Phone:** 86-021-31162222

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** zhuxiaofei_zxf@163.com

- **Name:** Xiaofei Zhu, M.D.

- **Phone:** 86-021-31162222

- **Role:** CONTACT

***Contact 2:***

- **Name:** Huojun Zhang, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Huojun Zhang

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200433

#### Overall Officials

**Official 1:**

**Affiliation:** Changhai Hospital

**Name:** Huojun Zhang, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2985

- Name: Gemcitabine

- Relevance: LOW

- As Found: Unknown

- ID: M377

- Name: Capecitabine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
