NCT00047112 · CITED IN SOURCE DOCUMENTS

Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2020-03-30

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Diagnosis of stage I or II thoracic esophageal cancer * Tumor no greater than 3 cm with no invasion of mediastinal structures with or without extension to the lymph nodes (T1-2, N0-1, M0) OR * Tumor greater than 3 cm with no invasion of mediastinal structures and no adenopathy greater than 1 cm (T3, N0, M0) * Epidermoid carcinoma or adenocarcinoma * Previously untreated * Deemed resectable with curative intent * No carcinoma in situ * No small cell anaplastic carcinoma (i.e., chromogranin negative) * No small cell neuroendocrine carcinoma (i.e., chromogranin positive) * No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm apart) * No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus (i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch) * No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT scan (simple compression allowed) * No signs of mediastinal involvement on CT scan * No palpable subclavicular lymph nodes or involvement after cytology needle aspiration * No lymph nodes from the origin of the celiac greater than 1 cm on CT scan * Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed unless tumor is more than 30 mm on CT scan PATIENT CHARACTERISTICS: Age * Under 75 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * SGOT/SGPT ratio no greater than 1 * Albumin at least 35 g/L * Total protein greater than 80% * No liver cirrhosis with previous failure * No ascites * No jaundice * No rupture of varicose esophageal veins * No presence of varicose esophageal veins Renal * Creatinine no greater than 1.25 times normal Cardiovascular * Arterial O\_2 greater than 60 mm Hg * Arterial CO\_2 no greater than 45 mm Hg * No myocardial infarction within the past 6 months * No progressive coronary artery disease grade 2 or greater * No recent left ventricular failure * No arterial disease stage II-IV Pulmonary * FEV\_1 greater than 1 L/sec Other * Able to receive either study treatment * No recurrent paralysis * No weight loss greater than 10% from baseline * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant * Fertile patients must use effective contraception during and for 3 months after completion of chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
healthy Volunteers: false
maximum Age: 74 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
intervention Names
Drug: cisplatin
Drug: fluorouracil
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
label
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
type
EXPERIMENTAL
description
CHIRURGIE SEULE
intervention Names
Procedure: conventional surgery
label
CHIRURGIE SEULE
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
name
cisplatin
type
DRUG
arm Group Labels
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
name
fluorouracil
type
DRUG
arm Group Labels
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIRURGIE SEULE
name
conventional surgery
type
PROCEDURE
arm Group Labels
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
name
neoadjuvant therapy
type
PROCEDURE
arm Group Labels
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 195
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
overal survival
time Frame
2010

secondary Outcomes

measure
recurrence free survival
time Frame
2010

Full study description

brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.
detailed Description: OBJECTIVES: * Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone. * Compare the disease-free survival of patients treated with these regimens. * Compare the surgical mortality and morbidity of patients treated with these regimens. * Compare the resectability of patients treated with these regimens. * Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection. * Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.

Source references

references

citation
Mariette C, Robb WB, Piessen G. Reply to Letter: "The Role of Surgery for Patients With a Complete Clinical Response After Chemoradiation for Esophageal Cancer". Ann Surg. 2015 Dec;262(6):e101-2. doi: 10.1097/SLA.0000000000000668. No abstract available.
pmid
24670853
type
BACKGROUND
citation
Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
pmid
24982463
type
RESULT
citation
Robb WB, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francaise de Cancerologie Digestive, Societe Francaise de Radiotherapie Oncologique, Union des Centres de Lutte Contre le Cancer, Groupe Cooperateur Multidisciplinaire en Oncologie, French EsoGAstric Tumour working group, Federation de Recherche En Chirurgie. Impact of neoadjuvant chemoradiation on lymph node status in esophageal cancer: post hoc analysis of a randomized controlled trial. Ann Surg. 2015 May;261(5):902-8. doi: 10.1097/SLA.0000000000000991.
pmid
25361220
type
RESULT
citation
Robb WB, Messager M, Dahan L, Mornex F, Maillard E, D'Journo XB, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francophone de Cancerologie Digestive; Societe Francaise de Radiotherapie Oncologique; Union des Centres de Lutte Contre le Cancer; Groupe Cooperateur Multidisciplinaire en Oncologie; French EsoGAstric Tumour working group - Federation de Recherche En Chirurgie. Patterns of recurrence in early-stage oesophageal cancer after chemoradiotherapy and surgery compared with surgery alone. Br J Surg. 2016 Jan;103(1):117-25. doi: 10.1002/bjs.9959. Epub 2015 Oct 29.
pmid
26511668
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-bfd5e95cca8e4340e587
requested nct id
NCT00047112
primary nct id
NCT00047112
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/esophageal/hp/esophageal-treatment-pdq
source record id
Source null
source file sha256
ae34307bb691d47c46a65f222a59b130903b0bb6f81f74d86efa8d978235c117
payload sha256
1b8c2a5b772b5783e43a6f89c3ba514ce222378c4269ceabe129cb77c71be24f
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-bfd5e95cca8e4340e587
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT00047112
occurrences
context exact
roversial. Although the CROSS study included early-stage patients, the Francophone de Cancérologie Digestive (FFCD) 9901 study (<a href="/clinicaltrials/NCT00047112">NCT00047112</a>),[<a href="#cit/section_4.25">25</a>] which included only early-stage (stage I or II) patients, failed to demonstrate a survival advantage in
end
139460
exact text
NCT00047112
start
139449
context exact
lthough the CROSS study included early-stage patients, the Francophone de Cancérologie Digestive (FFCD) 9901 study (<a href="/clinicaltrials/NCT00047112">NCT00047112</a>),[<a href="#cit/section_4.25">25</a>] which included only early-stage (stage I or II) patients, failed to demonstrate a survival advantage in this group of
end
139473
exact text
NCT00047112
start
139462
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/18487e92114483e1e7.html
source file sha256
ae34307bb691d47c46a65f222a59b130903b0bb6f81f74d86efa8d978235c117
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:21:40.423603+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
a637b94429a42b90c83abf50e8a31e75014f7c2723832c386417963ac519dbcf
source title
Esophageal Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: March 21, 2025
datetime
2025-03-21T12:00:00Z
display
March 21, 2025
source url
https://www.cancer.gov/types/esophageal/hp/esophageal-treatment-pdq

Preserved source evidence · Not medical advice