Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

NCT00112697 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000430095FRE-FNCLCC-ACCORD-09/0201EU-20511
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months

Secondary Outcomes (3)

• Toxicity

• Objective response rate

• Overall survival

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: docetaxel; Drug: fluorouracil; Radiation: radiation therapy

Arm 2

EXPERIMENTAL

Drug: cisplatin; Drug: docetaxel; Radiation: radiation therapy

Interventions

cisplatin DRUG

Arm 2

docetaxel DRUG

Arm 1; Arm 2

fluorouracil DRUG

Arm 1

radiation therapy RADIATION

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * No other pancreatic tumor type, including either of the following: * Neuroendocrine tumor * Ampulla of Vater carcinoma * Metastatic disease * Measurable or evaluable disease * Unresectable disease, defined as either of the following: * Failed prior attempt of surgical resection by laparotomy * Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion) * No cerebral metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal * No hepatic disturbance Renal * Creatinine \< 120 mmol/L Cardiovascular * No untreated cardiac or coronary insufficiency * No uncontrolled symptomatic arrhythmia * No uncontrolled angina Pulmonary * No uncontrolled respiratory insufficiency Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy ≥ grade 2 * No ongoing active infection * No other serious uncontrolled medical disorder that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the celiac or pancreatic area Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (10)

Centre Paul Papin

Angers, 49036, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

• Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

  PMID: 21943032 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin; Docetaxel; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Michel Ducreux, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: October 6, 2003
• Primary Completion: August 1, 2008
• Study Completion: March 1, 2012
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

FR (10)