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

Esophageal Cancer Clinical Trial

Official title:

Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416858
• Other study ID #: CDR0000453783
• Secondary ID: FFCD-9102EU-2053
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2006
• Last updated: March 3, 2014
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

References & Publications (5)

Bedenne L, Michel P, Bouché 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: FF — View Citation

Bonnetain F, Bouché 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 tr — View Citation

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 — View Citation

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 esophage — View Citation

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,