Image-Guided Radiation Therapy for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Elizabeth A Kidd

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Stanford University

Disqualifiers: Other cancer, Previous pelvic radiation, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a research study using Granulocyte Colony Stimulating Factor (GCSF) as a bone marrow stimulating agent for imaging to guide radiation treatment planning. G-CSF is a type of growth factor. Growth factors are proteins made in the body. G-CSF is a type of growth factor that makes the bone marrow produce white blood cells to reduce the risk of infection after some types of cancer treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug G-CSF (Granulocyte Colony Stimulating Factor) in treating cervical cancer?

The research indicates that the addition of GM-CSF (a similar growth factor to G-CSF) to chemotherapy in cervical cancer patients showed promising response rates and survival outcomes, suggesting potential benefits of using growth factors like G-CSF in treatment. ^{1 2 3 4 5}

Is Image-Guided Radiation Therapy for Cervical Cancer using G-CSF treatments like Pegfilgrastim safe?

G-CSF treatments like Pegfilgrastim are generally safe and widely used to reduce chemotherapy-induced neutropenia (low white blood cell count). Common side effects include pain and fever, while serious side effects like aortitis (inflammation of the aorta) are rare. ^{6 7 8 9 10}

How does image-guided radiation therapy differ from other treatments for cervical cancer?

Image-guided radiation therapy for cervical cancer is unique because it uses advanced imaging techniques to precisely target the tumor, allowing for higher doses of radiation to be delivered directly to the cancer while minimizing damage to surrounding healthy organs. This approach improves pelvic control and survival rates compared to traditional radiation therapy. ^{3 5 11 12 13}

Research Team

Elizabeth A Kidd

Principal Investigator

Stanford Universiy

Eligibility Criteria

This trial is for individuals with certain stages of cervical or endometrial cancer who haven't had pelvic radiation, other cancer treatments in the past 2 years, or conditions preventing chemotherapy. They must have good kidney and bone marrow function, an ECOG performance status of 0-2, and be able to consent.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document.

My blood tests show normal white cell and platelet counts.

My kidney function is within the normal range.

Exclusion Criteria

I cannot undergo chemotherapy due to a medical condition.

I have had radiation therapy to my pelvic area before.

You have received treatment for another type of cancer within the past two years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Phase I involves dose finding with GCSF in cohorts to determine the optimal dose for phase II

12 months

Weekly visits for CBC and differential checks

Treatment

Participants receive chemoradiation with GCSF at the optimal dose determined in phase I

33 months

Weekly visits for CBC and differential checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GCSF (Growth Factor)

Trial Overview The study tests using GCSF (a growth factor that stimulates white blood cell production) along with FDG-PET/CT imaging to guide radiation therapy planning for better bone marrow sparing in treating cervical and endometrial cancers.

Participant Groups

Group I: Phase II-G-CSF Experimental Treatment 2 Interventions

Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.

Group II: Phase I -Dose finding, Cohort 3 Experimental Treatment 2 Interventions

Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day

Group III: Phase I -Dose finding, Cohort 2 Experimental Treatment 2 Interventions

Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days

Group IV: Phase I -Dose finding, Cohort 1 Experimental Treatment 2 Interventions

Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

Both volumetric-modulated arc therapy (VMAT) and helical tomotherapy (HT) provide effective coverage for target volumes in extended-field bone marrow-sparing radiotherapy for cervical cancer, ensuring good dose homogeneity and conformity while protecting surrounding organs.

VMAT is more efficient than HT, as it requires significantly fewer monitor units and shorter treatment times, making it a preferable option for patients undergoing this type of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-field bone marrow sparing radiotherapy for primary chemoradiotherapy in cervical cancer patients with para-aortic lymphadenopathy: Volumetric-modulated arc therapy versus helical tomotherapy. Chen, JL., Wang, MC., Huang, YS., et al.[2021]

Chemotherapy combined with radiation therapy has significantly improved overall survival rates in patients with locally advanced cervical carcinoma, with weekly cisplatin (40 mg/m²) showing the best response compared to other combinations.

Despite the exploration of various other cytotoxic and biologic agents, no treatment has proven to be more effective than weekly cisplatin in conjunction with radiotherapy, which remains the standard therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel chemotherapy approaches in chemoradiation protocols. González-Cortijo, L., Carballo, N., González-Martín, A., et al.[2008]

Sonifilan (SPG), a glucan from Schizophyllum commune, showed superior effects in controlling human uterine cervix cancer compared to radiation therapy alone, indicating its potential as an effective treatment option.

SPG not only enhanced the effectiveness of radiation therapy in reducing primary tumors but also significantly suppressed experimental lung metastasis, suggesting a synergistic effect when combined with radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improvement in the effects of radiation therapy with BRM]. Inomata, T., Ogawa, Y., Nishioka, A., et al.[2018]

In a study of 60 cervical cancer patients undergoing chemoradiotherapy, the use of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) significantly reduced the incidence of severe neutropenia (grade 3-4) to 10% compared to 77.78% in the control group (P < 0.001).

PEG-rhG-CSF also decreased the incidence of grade 4 neutropenia and febrile neutropenia, leading to fewer delays in chemotherapy cycles, while the overall safety profile was better in the experimental group with fewer adverse events (55% vs. 94.44%, P = 0.003).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer. Zou, D., Guo, M., Zhou, Q.[2021]

Pegfilgrastim is as effective or even more effective than filgrastim in reducing chemotherapy-induced neutropenia, making it a strong option for patients undergoing cancer treatment.

One of the key benefits of pegfilgrastim is that it can be administered just once per chemotherapy cycle, which may improve patient compliance and enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. Morishita, M., Leonard, RC.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term survival of patients with advanced/recurrent carcinoma of cervix and vagina after neoadjuvant treatment with methotrexate, vinblastine, doxorubicin, and cisplatin with or without the addition of molgramostim, and review of the literature. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Extended-field bone marrow sparing radiotherapy for primary chemoradiotherapy in cervical cancer patients with para-aortic lymphadenopathy: Volumetric-modulated arc therapy versus helical tomotherapy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Novel chemotherapy approaches in chemoradiation protocols. [2008]

4. Japan pubmed.ncbi.nlm.nih.gov

[Improvement in the effects of radiation therapy with BRM]. [2018]

5. Singapore pubmed.ncbi.nlm.nih.gov

Radiation therapy with concomitant and adjuvant cisplatin and paclitaxel in high-risk cervical cancer: long-term follow-up. [2020]

6. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Efficacy and safety of PEG-rhG-CSF in preventing chemoradiotherapy-induced neutropenia in patients with locally advanced cervical cancer. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Pegfilgrastim-Induced Aortitis in a Patient with Small-Cell Lung Cancer Who Received Immunotherapy Combined with Chemotherapy. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Pegfilgrastim. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A clinical study of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of LC9018 combined with radiation therapy on carcinoma of the uterine cervix. A phase III, multicenter, randomized, controlled study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Three-dimensional high dose rate intracavitary image-guided brachytherapy for the treatment of cervical cancer using a hybrid magnetic resonance imaging/computed tomography approach: feasibility and early results. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. [2022]