Know Cancer

or
forgot password

Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)


Phase 4
18 Years
N/A
Not Enrolling
Female
Anemia, Cervical Cancer

Thank you

Trial Information

Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)


OBJECTIVES:

- Compare the effectiveness of epoetin beta vs standard care for anemia management, in
terms of increased hemoglobin levels and the correlation with reduced relapse/treatment
failure rate, in patients with stage IIB, III, or IVA cervical cancer treated with
cisplatin and radiotherapy.

- Compare the safety of these regimens in these patients.

- Compare the relapse-free and overall survival of patients treated with these regimens.

- Compare the frequency and localization of relapses and metastases in patients treated
with these regimens.

- Compare the quality of life of patients treated with these regimens.

- Compare the type, frequency, and degree of adverse events in patients treated with
these regimens.

- Compare the overall response rate in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are
stratified according to country, disease stage, and brachytherapy technique. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients also undergo
high-dose rate, low-dose rate, or boost brachytherapy. Patients receive cisplatin IV
beginning on day 1 of radiotherapy and continuing weekly for 6 weeks. Patients also
receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before
radiotherapy and continuing for 8 weeks.

- Arm II: Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm
I.

Quality of life is assessed at baseline, after the last treatment, and at 3 months.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 80-450 patients will be accrued for this study within 4-22.5
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IIB, III, or IVA cervical cancer

- No chorion carcinoma or neuroendocrine small cell carcinoma

- Previously untreated disease

- Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy

- Hemoglobin 8.0-13.0 g/dL

- No relevant acute bleeding within the past 3 months, including anemia caused by gross
bleeding from tumor

- No distant metastasis

- No positive para-aortic lymph nodes

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- WHO 0-2

Life expectancy

- At least 3 months

Hematopoietic

- See Disease Characteristics

- WBC greater than 3,000/mm3

- Platelet count greater than 100,000/mm3

- No hemolytic anemia

- No transferrin saturation less than 20% that cannot be treated with IV iron

- No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types)

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Transaminases no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal

- Creatinine clearance greater than 60 mL/min

Cardiovascular

- No chronic heart failure

- No New York Heart Association class II-IV heart disease

- No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg,
diastolic blood pressure at least 100 mmHg)

- No prior deep vein thrombosis

- No thrombocytosis

Other

- No vitamin B12 deficiency

- No folic acid deficiency

- No newly diagnosed (unstable) epilepsy

- No acute infection

- No other malignancy within the past 5 years except basal cell carcinoma in situ

- No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater

- No impaired hearing grade 2 or greater

- No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any
excipients of cisplatin preparations

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 months since prior epoetins or related compounds

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior radiotherapy for cervical cancer

Surgery

- Not specified

Other

- At least 30 days since prior investigational drugs

- No prior systemic antineoplastic therapy for cervical cancer

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)

Principal Investigator

Heinz Koelbl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Martin-Luther-Universit├Ąt Halle-Wittenberg

Authority:

United States: Federal Government

Study ID:

AGOSG-OVAR-MO16375-MARCH

NCT ID:

NCT00046969

Start Date:

July 2002

Completion Date:

June 2007

Related Keywords:

  • Anemia
  • Cervical Cancer
  • anemia
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • Anemia
  • Uterine Cervical Neoplasms

Name

Location