Clinical trial NCT00253409: Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
Official title: Mesothelioma and Radical Surgery Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Mesothelioma
Keywords: localized malignant mesothelioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-11-15
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without surgery and radiation therapy in treating mesothelioma.

PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and radiation therapy to see how well they work compared to combination chemotherapy alone in treating patients with mesothelioma that can be removed by surgery.

Detailed description: OBJECTIVES:

* Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma.
* Compare the overall survival of patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter, pilot study followed by a randomized, controlled study.

Patients undergo 3 courses of a platinum-based (cisplatin or carboplatin) combination chemotherapy regimen to be determined by the treatment center. Upon completion of combination chemotherapy, patients are randomized to 1 of 2 treatment arms provided tumor is resectable and there is no disease progression.

* Arm I: Patients undergo extra-pleural pneumonectomy followed by post-operative radiotherapy.
* Arm II: Patients undergo follow-up only. Patients may receive additional standard therapy according to their treatment center.

Quality of life is assessed at baseline, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 50-670 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically and immuno-histochemically confirmed malignant mesothelioma

  * Resectable disease (T1-3, N0-1, M0) with no distant metastases
* Eligible to undergo extra-pleural pneumonectomy based on British Thoracic Society guidelines

PATIENT CHARACTERISTICS:

Performance status

* WHO 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Normal renal function

Cardiovascular

* Ejection fraction ≥ 40%

Pulmonary

* Predicted post-operative FEV_1 ≥ 40%
* Predicted post-operative DLCO ≥ 40%
* No significant pulmonary hypertension

Other

* No physical or personal condition that would preclude ability to undergo chemotherapy or post-operative radiotherapy
* No physical or personal condition that would preclude ability to comply with follow-up requirements

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: England
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: England
city: London
country: United Kingdom
facility: St. Thomas' Hospital
state: England
city: London
country: United Kingdom
facility: Royal Marsden - London
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Sutton
country: United Kingdom
facility: Institute of Cancer Research - Sutton
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Clare Peckitt
role: STUDY_CHAIR
References: