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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00416858
First received: December 27, 2006
Last updated: March 3, 2014
Last verified: April 2007

December 27, 2006
March 3, 2014
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April 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00416858 on ClinicalTrials.gov Archive Site
Not Provided
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Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
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NCT00416858
CDR0000453783, FFCD-9102, EU-20539, ESSAI-FFCD-9102
Not Provided
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Not Provided
Study Chair: Laurent Bedenne, MD Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP