Know Cancer

or
forgot password

A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.


Determined treatment efficacy and tolerability of second-line treatment in patients with
small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination
chemotherapy.


Inclusion Criteria:



- Small-cell lung cancer.

- Patients who, after (at least) a first line of chemotherapy based on platinum, had a
partial response and then progressed, or who had a complete response and then
relapsed within three months following the last course of this first-line therapy.

- Measurable or assessable disease.

- Life expectancy >2 months.

- Patients with a therapeutic risk level of <5 points (see section 6: "Treatment
flowchart").

- Age >18 years;

- Performance status (WHO) <2;

- One measurable target lesion in a non irradiated region;

- Prior radiotherapy authorized unless it targeted the only measurable lesion;

- Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3,
creatinemia <2 x ULN, bilirubinemia metastases)

- normal ECG

- written informed consent.

Exclusion Criteria:

- Non small-cell lung cancer.

- No objective response to platinum-based therapy

- Complete response lasting more than three months after the last course of first-line
treatment.

- Symptomatic brain metastases.

- Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable
disease manifestations.- Concurrent participation in another clinical trial.

- Therapeutic risk level of 6 points or more (see table)

- Uncontrolled clotting disorders;

- Uncontrolled severe infection;

- History of another malignancy, except for cervical carcinoma in situ or basocellular
cancer that are considered cured;

- Psychological, familial, sociological or geographic circumstances preventing
treatment follow-up as defined in the protocol;

- Patients deprived of their rights for administrative or legal reasons.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Christos CHOUAID, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Francais De Pneumo-Cancerologie

Authority:

France: Institutional Ethical Committee

Study ID:

GFPC 05-01

NCT ID:

NCT00418743

Start Date:

December 2005

Completion Date:

May 2010

Related Keywords:

  • Small Cell Lung Cancer
  • cancer
  • Lung cancer
  • small-cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location