Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery - Full Text View

Sponsored by:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416858

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain.

PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Condition	Intervention	Phase
Esophageal Cancer	Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:

40

Detailed Description:

OBJECTIVES:

Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy.
Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).

Induction therapy: All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks. Patients achieving complete or partial response are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo surgery. Patients may receive 1 course of adjuvant chemotherapy (as in induction therapy) and undergo additional radiotherapy.
Arm II: Patients receive additional fluoroucacil and cisplatin as in induction therapy. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks. Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:
- Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement
- T3, N0-N1 disease
- Tumor extends into fifth stratum by endosonographic scan
- Resectable disease (palliative or curative)
No cervical tumor
No T1, T2, or T4 tumors
No tracheo-esophageal fistula or tracheal invasion
No gastric cardia cancer by gastroscopy
No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Creatinine normal
WBC ≥ 3,000/mm^3
Neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Transaminases ≥ 60%
Bilirubin ≤ 2.0 mg/dL
No cirrhosis
DLCO ≥ 1.5 L with or without hypoxemia at rest
No progressive coronary insufficiency
Weight loss ≤ 15%
No other malignancy in the past 2 years
Must be able to maintain sufficient enteral nutrition (2,000 calories/day)
- Laser photodestruction, dilation, or gastric balloon allowed
No contraindication to radiotherapy
No recurring left paralysis

PRIOR CONCURRENT THERAPY:

No concurrent nephrotoxic or myelotoxic drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416858

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

Study Chair:

Laurent Bedenne, MD

Federation Francophone de Cancerologie Digestive

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Burtin P, Bouché O, Giovannini M, Pelletier M, Conroy T, Ruget O, Arsène D, Milan C, Bedenne L. Endoscopic ultrasonography is an independent predictive factor of prognosis in locally advanced esophageal cancer. Results from the randomized FFCD 9102 study from the Fédération francophone de cancérologie digestive. Gastroenterol Clin Biol. 2008 Mar 25; [Epub ahead of print]

Jouve J, Michel P, Mariette C, et al.: Outcome of the nonrandomized patients in the FFCD 9102 trial: chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus. [Abstract] J Clin Oncol 26 (Suppl 15): A-4555, 2008.

Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8.

Crehange G, Maingon P, Peignaux K, N'guyen TD, Mirabel X, Marchal C, Verrelle P, Roullet B, Bonnetain F, Bedenne L; Federation Francophone de Cancerologie Digestive 9102. Phase III trial of protracted compared with split-course chemoradiation for esophageal carcinoma: Federation Francophone de Cancerologie Digestive 9102. J Clin Oncol. 2007 Nov 1;25(31):4895-901.

Bonnetain F, Bouche O, Michel P, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Paillot B, Arveux P, Milan C, Bedenne L. A comparative longitudinal quality of life study using the Spitzer quality of life index in a randomized multicenter phase III trial (FFCD 9102): chemoradiation followed by surgery compared with chemoradiation alone in locally advanced squamous resectable thoracic esophageal cancer. Ann Oncol. 2006 May;17(5):827-34. Epub 2006 Mar 8.

Study ID Numbers:	CDR0000453783, FFCD-9102, EU-20539, ESSAI-FFCD-9102
Study First Received:	December 27, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00416858 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III esophageal cancer

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Esophageal Neoplasms
Adjuvants, Immunologic
Esophageal Cancer
Immunosuppressive Agents

Digestive System Diseases
Cisplatin
Esophageal Disorder
Head and Neck Neoplasms
Fluorouracil
Gastrointestinal Neoplasms
Esophageal Diseases

Additional relevant MeSH terms:

Antimetabolites
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Physiological Effects of Drugs
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Fluorouracil
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 11, 2009