Back to results

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Docetaxel

Cisplatin

Capecitabine

Radiation

Capecitabine

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Adjuvant Gastric Cancer, Adjuvant chemotherapy, Adjuvant chemo-radiation, Capecitabine

Eligibility Criteria

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

Inclusion Criteria:

Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0
No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason
Patients must have a life expectancy of at least 16 weeks and a performance status of < 2 ECOG scale
Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl
Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

Patients with T1N0 carcinoma
Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively)
Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes
Evidence of metastatic disease to distant organs
Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection
Patients with diabetic neuropathy
Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin)
Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment

Sites / Locations

University Hospital of Crete Dept of Medical Oncology
University General Hospital of Alexandroupolis, Dep of Medical Oncology
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
401 Military Hospital of Athens
Air Forces Military Hospital of Athens
General Hospital of Larissa Dept of Medical Oncology
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

TCX ->RT -> TCX

Outcomes

Primary Outcome Measures

The proportion of patients completing protocol therapy (feasibility)

Secondary Outcome Measures

Toxicity profile

Overall survival

Full Information

NCT ID

NCT00718913

First Posted

July 18, 2008

Last Updated

May 14, 2015

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00718913

Brief Title

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Official Title

A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.

Detailed Description

Patients with localized gastric cancer often relapse either locally or systemically. A strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved the feasibility of administering FOLFIRI regimen as adjuvant chemotherapy combined with adjuvant chemoradiation in patients with excised with curative intend gastric cancer. It would be important to improve the treatment involving active regimen as adjuvant chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.

6. Conditions and Keywords

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

Gastric Cancer

Keywords

Adjuvant Gastric Cancer, Adjuvant chemotherapy, Adjuvant chemo-radiation, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

TCX ->RT -> TCX

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).

Intervention Type

Radiation

Intervention Name(s)

Radiation

Other Intervention Name(s)

Intervention Description

At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).

Primary Outcome Measure Information:

Title

The proportion of patients completing protocol therapy (feasibility)

Time Frame

The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered

Secondary Outcome Measure Information:

Title

Toxicity profile

Time Frame

Toxicity assessment on each cycle

Title

Toxicity profile

Time Frame

Toxicity assessment on each chemotherapy cycle

Title

Overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0 No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason Patients must have a life expectancy of at least 16 weeks and a performance status of < 2 ECOG scale Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study. Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl Patients must be able to understand the nature of this study and give written informed consent Exclusion Criteria: Patients with T1N0 carcinoma Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively) Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes Evidence of metastatic disease to distant organs Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection Patients with diabetic neuropathy Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin) Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ioannis Boukovinas, MD

Organizational Affiliation

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Crete Dept of Medical Oncology

City

Heraklion

State/Province

Crete

Country

Greece

Facility Name

University General Hospital of Alexandroupolis, Dep of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

City

Athens

Country

Greece

Facility Name

401 Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

General Hospital of Larissa Dept of Medical Oncology

City

Larissa

Country

Greece

Facility Name

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

City

Piraeus

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

We'll reach out to this number within 24 hrs