Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

NCT00416507 | Completed Phase 3

• 4 other identifiers: CDR0000453847FFCD-2000-01EU-20542FFCD-SFRO-2000-01
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer. PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer; stage II pancreatic cancer

Interventions

fluorouracil DRUG

gemcitabine hydrochloride DRUG

liposomal cisplatin DRUG

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * No neuroendocrine or other histologies * No extra-abdominal metastases * No hepatic or peritoneal metastases by celioscopy * Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed * Nonresectable disease meeting ≥ 1 of the following criteria: * Arterial invasion * Mesenteric-portal vein invasion \> 15 mm and or less than hemicircumference * Satellite adenopathies encompassed in the radiation field PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Bilirubin \< 1.75 mg/dL * Creatinine \< 1.5 mg/dL * WBC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * No major organ disorder, including cardiac or coronary insufficiency * Prothrombin time \> 80% * No psychiatric or social condition that would preclude study therapy * No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * No contraindications to radiotherapy or chemotherapy * No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy PRIOR CONCURRENT THERAPY: * No prior adjuvant or palliative chemotherapy or radiotherapy * Prior surgical diversion of the biliary and/or digestive tract allowed

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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Related Publications (2)

• Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, Bosset JF, Aparicio T, Mineur L, Azzedine A, Hammel P, Butel J, Stremsdoerfer N, Maingon P, Bedenne L. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol. 2008 Sep;19(9):1592-9. doi: 10.1093/annonc/mdn281. Epub 2008 May 7.

  PMID: 18467316 RESULT

• Mornex F, Chauffert B, Bonnetain F, et al.: Definitive results of the French FFCD-SFRO 2000-01 study: phase III trial comparing chemoradiotherapy (cisplatin and infusional 5-FU) followed by gemcitabine vs. gemcitabine alone in patients with locally advanced non metastatic pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-135, S77, 2007.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Gemcitabine; SPI-77, liposomal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• Francoise Mornex, MD, PhD

  Centre Hospitalier Lyon Sud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: March 1, 2000
• Primary Completion: July 1, 2005
• Study Completion: January 1, 2007
• Last Updated: May 30, 2016

Record last verified: 2016-05