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Platinum-based Chemotherapy

Chemo-Radiation for Early-Stage Cervical Cancer

Phase 3

Waitlist Available

Led By Anuja Jhingran, MD

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

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

Must have

No neuroendocrine histology

No distant metastases

Must not have

Chronic obstructive pulmonary disease exacerbation or other respiratory illness precluding study therapy at study entry

Overlap of radiotherapy fields due to prior radiotherapy to the pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death or last follow-up. maximum follow-up time at time of analysis was 12.8 years. the 2- and 4-year survival estimates are reported.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying how well giving chemotherapy and pelvic radiation therapy together with or without additional chemotherapy works in treating patients with high-risk early-stage cervical cancer.

Who is the study for?

This trial is for patients with high-risk early-stage cervical cancer who've had a radical hysterectomy. Eligible participants must have certain types of cervical cancer, no distant metastases, and their major organs functioning well. They should not have received prior chemotherapy or pelvic radiotherapy for the current cancer and must not have severe active co-morbidities.

What is being tested?

The study is testing how effective chemotherapy (cisplatin, paclitaxel, carboplatin) combined with pelvic radiation therapy is compared to the same treatment plus additional chemotherapy in treating high-risk early-stage cervical cancer post-surgery.

What are the potential side effects?

Chemotherapy drugs like cisplatin, paclitaxel, and carboplatin can cause side effects including nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, kidney problems and nerve damage which might lead to numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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My cancer does not have neuroendocrine features.

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My cancer has not spread to distant parts of my body.

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I can carry out all my usual activities without help.

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My PET scans show no cancer in the para-aortic nodes.

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My cancer does not have large, visible tumors after surgery.

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My cervical cancer surgery showed high-risk features but no spread to para-aortic nodes.

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My cancer is in an early stage (IA2, IB, IIA).

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I have had lymph node sampling in my pelvis and near my aorta.

Exclusion Criteria

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

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I do not have a severe lung condition that would stop me from joining the study.

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I have had previous radiation treatment to my pelvis.

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I have not been hospitalized for heart issues in the last 6 months.

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I am receiving IV antibiotics for a bacterial or fungal infection.

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I have had chemotherapy for my current cervical cancer.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death or last follow-up. maximum follow-up time at time of analysis was 12.8 years. the 2- and 4-year survival estimates are reported.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death or last follow-up. maximum follow-up time at time of analysis was 12.8 years. the 2- and 4-year survival estimates are reported.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death or last follow-up. maximum follow-up time at time of analysis was 12.8 years. the 2- and 4-year survival estimates are reported. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease-free Survival (Percentage of Participants Alive Without Disease)

Secondary study objectives

Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months

Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months

+2 more

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667

46%

Platelet count decreased

38%

Nausea

23%

Fatigue

23%

White blood cell decreased

23%

Vomiting

23%

Chills

23%

Dyspnea

15%

Creatinine increased

15%

Urinary tract infection

15%

Anemia

15%

Weight loss

15%

Investigations-other

15%

Back pain

15%

Paresthesia

15%

Epistaxis

Non-cardiac chest pain

Alkaline phosphatase increased

Peripheral sensory neuropathy

Infections and infestations-others

Bone pain

Sinus bradycardia

Eyelid function disorder

General disorders and administration site conditions-other

Diarrhea

Bronchial infection

Nail infection

Fever

Upper respiratory infection

Confusion

Tachyarrhythmia

Gastrointestinal hermorrhage

Ileus

General disorders-other

Catheter related infection

Hematuria

Urinary tract obstruction

Pleural effusion

Vertigo

Endocrine disorders-other

Neutrophil count decreased

Arthralgia

Pain in extremity

Neck pain

Generalized muscle weakness

Neoplasms benign, malignant and unspecified-others

Depression

Alopecia

Nail ridging

Surgical and medical procedures-others

Chill

Gastrointestinal hemorrhage

Arthritis

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab/Gemcitabine/Cisplatin

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II: Cisplatin/Radiation Therapy + Carboplatin/PaclitaxelExperimental Treatment6 Interventions

Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I: Cisplatin/Radiation TherapyActive Control4 Interventions

Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

intensity-modulated radiation therapy

2008

Completed Phase 3

~1490

carboplatin

2010

Completed Phase 3

~4790