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Alkylating agents

Chemoradiation + Chemotherapy for Cervical Cancer

Phase 1

Waitlist Available

Led By Cecelia H Boardman

Research Sponsored by Gynecologic Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine =< institutional upper limit normal (ULN); Note: if creatinine > ULN, creatinine clearance must be > 50 mL/min

Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

Must not have

Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy

Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing paclitaxel and carboplatin as a follow-up to cisplatin and radiation therapy for cervical cancer patients to see if it is more effective in killing tumor cells.

Who is the study for?

This trial is for patients with confirmed cervical cancer stages IB-IVA who have positive para-aortic lymph nodes. They must be in good physical condition, not pregnant, and able to follow the study's procedures. Excluded are those with active infections, recent major surgery, significant heart disease, previous treatments for this cancer or other invasive malignancies within five years.

What is being tested?

The trial tests how well paclitaxel and carboplatin work after initial treatment with cisplatin and radiation therapy in cervical cancer patients. It aims to find the best dose of chemotherapy following radiation to kill more tumor cells.

What are the potential side effects?

Chemotherapy drugs like cisplatin, paclitaxel, and carboplatin can cause side effects including nausea, fatigue, hair loss, nerve damage (neuropathy), blood cell count changes increasing infection risk; kidney function may also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels, is within the normal range.

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I have had a stent or tube placed for my blocked ureter before joining the study.

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I can take care of myself but might not be able to do heavy physical work.

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My nerve damage symptoms are mild or not present.

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My cervical cancer is confirmed and has spread to the lymph nodes near my aorta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation, chemotherapy, or any treatment for my cancer before.

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I have a unique kidney condition that affects how radiation therapy is given.

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I currently have an active infection.

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I have not had major surgery, except for a biopsy, in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Objective tumor response rate in patients enrolled with measurable disease

Overall survival

Progression-free survival (PFS)

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation, cisplatin, paclitaxel, carboplatin)Experimental Treatment5 Interventions

Patients receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and undergo extended-field radiotherapy daily 5 days a week for 6 weeks followed by brachytherapy. Beginning 4-6 weeks after completion of chemoradiation, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Internal Radiation Therapy

2006

Completed Phase 3

~290

Carboplatin

FDA approved