Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Cisplatin and Docetaxel

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) Locally advanced disease that is technically operable with curative intent (R0) T3, N0 OR T1-3, N+ OR T4, NX No T1-2, N0 No inoperable T4 (unequivocal organ involvement) No distant metastasis, including M1a lymph node status Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology No carcinoma of the cervical esophagus Obstructive tumors allowed PATIENT CHARACTERISTICS: Age 18 to 70 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic AST no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance greater than 60 mL/min Cardiovascular No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No myocardial infarction within the past 3 months No significant arrhythmias No other severe or uncontrolled cardiovascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after study treatment No definite contraindications to corticosteroids as premedication No geographic situation that would preclude proper staging and follow-up No active uncontrolled infection No preexisting peripheral neuropathy greater than grade 1 No uncontrolled diabetes mellitus No active autoimmune disease No other serious medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Surgery Not specified Other More than 30 days since prior treatment on another clinical trial No other concurrent experimental drugs

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm A

Arm Description

Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery

Outcomes

Primary Outcome Measures

Feasibility of successful study therapy completion and survival after surgery

Secondary Outcome Measures

Adverse events

Overall survival

Feasibility in Switzerland after surgery

Full Information

NCT ID

NCT00072033

First Posted

November 4, 2003

Last Updated

June 2, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00072033

Brief Title

Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

Official Title

Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.

Detailed Description

OBJECTIVES: Primary Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer. Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients. Secondary Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results. Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Determine the clinical benefit of this regimen in these patients. OUTLINE: This is a multicenter study. Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22. Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks. Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery

Intervention Type

Drug

Intervention Name(s)

Cisplatin and Docetaxel

Intervention Description

cisplatin and docetaxel chemo- and radiochemotherapy

Primary Outcome Measure Information:

Title

Feasibility of successful study therapy completion and survival after surgery

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

30 days

Title

Overall survival

Time Frame

Life-long

Title

Feasibility in Switzerland after surgery

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) Locally advanced disease that is technically operable with curative intent (R0) T3, N0 OR T1-3, N+ OR T4, NX No T1-2, N0 No inoperable T4 (unequivocal organ involvement) No distant metastasis, including M1a lymph node status Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology No carcinoma of the cervical esophagus Obstructive tumors allowed PATIENT CHARACTERISTICS: Age 18 to 70 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic AST no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance greater than 60 mL/min Cardiovascular No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No myocardial infarction within the past 3 months No significant arrhythmias No other severe or uncontrolled cardiovascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after study treatment No definite contraindications to corticosteroids as premedication No geographic situation that would preclude proper staging and follow-up No active uncontrolled infection No preexisting peripheral neuropathy greater than grade 1 No uncontrolled diabetes mellitus No active autoimmune disease No other serious medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Surgery Not specified Other More than 30 days since prior treatment on another clinical trial No other concurrent experimental drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Ruhstaller, MD

Organizational Affiliation

Cantonal Hospital of St. Gallen

Official's Role

Study Chair

Facility Information:

Facility Name

Kantonspital Aarau

City

Aarau

ZIP/Postal Code

CH-5001

Country

Switzerland

Facility Name

Universitaetsspital-Basel

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

Inselspital Bern

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Spitaeler Chur AG

City

Chur

ZIP/Postal Code

CH-7000

Country

Switzerland

Facility Name

Hopital Cantonal Universitaire de Geneve

City

Geneva

ZIP/Postal Code

CH-1211

Country

Switzerland

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

ZIP/Postal Code

CH-1011

Country

Switzerland

Facility Name

Ospedale Civico

City

Lugano

ZIP/Postal Code

CH-6900

Country

Switzerland

Facility Name

Kantonsspital - St. Gallen

City

St. Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

City Hospital Triemli

City

Zurich

ZIP/Postal Code

8063

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20304399

Citation

Jost C, Binek J, Schuller JC, Bauerfeind P, Metzger U, Werth B, Knuchel J, Frossard JL, Bertschinger P, Brauchli P, Meyenberger C, Ruhstaller T. Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02). Gastrointest Endosc. 2010 Jun;71(7):1114-21. doi: 10.1016/j.gie.2009.12.015. Epub 2010 Mar 20.

Results Reference

result

PubMed Identifier

20016233

Citation

Klaeser B, Nitzsche E, Schuller JC, Koberle D, Widmer L, Balmer-Majno S, Hany T, Cescato-Wenger C, Brauchli P, Zund M, Pestalozzi BC, Caspar C, Albrecht S, von Moos R, Ruhstaller T. Limited predictive value of FDG-PET for response assessment in the preoperative treatment of esophageal cancer: results of a prospective multi-center trial (SAKK 75/02). Onkologie. 2009 Dec;32(12):724-30. doi: 10.1159/000251842. Epub 2009 Nov 9.

Results Reference

result

PubMed Identifier

19465425

Citation

Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.

Results Reference

result

Citation

Schuller JC, Balmer-Majno S, Mingrone W, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy (RT) in patients with locally advanced esophageal cancer: final results of the multicenter phase ll trial SAKK 75/02. [Abstract] J Clin Oncol 26 (Suppl 15): A-4550, 2008.

Results Reference

result

Citation

Ribi K, Nitzsche E, Schuller J, et al.: PET scanning and patient reported dysphagia before and after chemotherapy (CT) for prediction of pathological response after CT and chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer (EC): a multicenter phase ll trial of the Swiss. [Abstract] J Clin Oncol 25 (Suppl 18): A-4587, 2007.

Results Reference

result

Citation

Ruhstaller T, Widmer L, Majno SB, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy in patients with locally advanced esophageal cancer: a prospective, multicenter phase ll trial of the Swiss Group for Clinical Cancer Research. [Abstract] J Clin Oncol 25 (Suppl 18): A-4562, 2007.

Results Reference

result

PubMed Identifier

28742685

Citation

Steffen T, Dietrich D, Schnider A, Kettelhack C, Huber O, Marti WR, Furrer M, Gloor B, Schiesser M, Thierstein S, Brauchli P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK). Recurrence Patterns and Long-term Results After Induction Chemotherapy, Chemoradiotherapy, and Curative Surgery in Patients With Locally Advanced Esophageal Cancer. Ann Surg. 2019 Jan;269(1):83-87. doi: 10.1097/SLA.0000000000002435.

Results Reference

derived

Esophageal Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial